Indomethacin Oral Capsule

Brand(s)
Tivorbex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Iroko Pharmaceuticals, Llc (2015-06-04)
Oldest Current Product
1984-04-20
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\INDOMETHACIN
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\INDOMETHACIN
ORAL\CAPSULE\INDOMETHACIN
SPL Active
ORAL\CAPSULE\INDOMETHACIN
SPL Moiety
ORAL\CAPSULE\INDOMETHACIN

product(s) by strength(s)

indomethacin 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1422110201TivorbexNDAIroko Pharmaceuticals, Llc2015-07-06INDOMETHACINORALCAPSULENDA20476804ca474c-798e-43dd-be7a-1b36720e6a3d

indomethacin 25 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550010NDAHeritage Pharmaceuticals Inc.2010-07-30INDOMETHACINORALCAPSULENDA0188514babe1c2-15f2-40af-b326-b256507a921c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934029ANDATeva Pharmaceuticals Usa Inc2007-12-14INDOMETHACINORALCAPSULEANDA0707196422d983-a063-41ae-aa96-7ae2284cb123
2007812325ANDASandoz Inc1987-04-29INDOMETHACINORALCAPSULEANDA07067357c11bb8-d133-43e2-a74f-838c31296eb5
3317220542ANDACamber Pharmaceuticals, Inc.2011-11-01INDOMETHACINORALCAPSULEANDA0912401ce9c3c5-0cf7-4760-988d-2559adcfb200
4576640119ANDACaraco Pharmaceutical Laboratories, Ltd.2013-05-16INDOMETHACINORALCAPSULEANDA091401c70b5045-706e-443a-9be1-d0bc3c598130
5659775042ANDAHetero Drugs Ltd.,2011-04-12INDOMETHACINORALCAPSULEANDA091240110aada7-dfe8-4ecf-80c7-4dac8907ad29
6684620406ANDAGlenmark Generics Inc., Usa2010-12-22INDOMETHACINORALCAPSULEANDA091276f7ed39e2-5431-4e47-935c-c7441d058f94

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004401652NDALiberty Pharmaceuticals, Inc.2013-04-23INDOMETHACINORALCAPSULE003780143NDA018858e3f4420e-0052-4dbd-bb4b-7e7b76dc71ea
2105440234NDABlenheim Pharmacal, Inc.2013-11-15INDOMETHACINORALCAPSULE003780143NDA0188581193ebb6-26bb-646c-e054-00144ff88e88
3165900129NDAStat Rx Usa Llc2010-09-15INDOMETHACINORALCAPSULE003780143NDA018858b9e8ab78-ae95-4036-b756-84b0d6ef2fac
4216950522ANDARebel Distributors Corp2010-12-22INDOMETHACINORALCAPSULE684620406ANDA0912761f60d27b-fa95-40dd-969f-51f977142032
5242360132NDARemedyrepack Inc.2013-03-18INDOMETHACINORALCAPSULE003780143NDA01885873912f56-94a3-443b-a31a-8a246c411a08
6353560876ANDALake Erie Medical Dba Quality Care Products Llc2007-12-14INDOMETHACINORALCAPSULE000934029ANDA070719ad71bdc6-b47f-441c-9d05-279b3d81b975
7422540237NDARebel Distributors Corp2010-07-30INDOMETHACINORALCAPSULE231550010NDA0188514b8dbfb7-5f20-4398-937a-72ed536c57c4
8430630368ANDAPd-Rx Pharmaceuticals, Inc.2010-12-22INDOMETHACINORALCAPSULE684620406ANDA091276b4cf01d1-0d71-4f0f-97a5-07a59744149f
9430630594NDAPd-Rx Pharmaceuticals, Inc.2010-07-30INDOMETHACINORALCAPSULE231550010NDA01885185f68421-4773-4d88-a52f-6d07ece4a31f
10493490113ANDARemedyrepack Inc.2010-12-06INDOMETHACINORALCAPSULE000934029ANDA070719197c0496-3910-44ed-b8fb-df01b0f925a8
11500900052ANDAA-S Medication Solutions Llc2011-11-01INDOMETHACINORALCAPSULE317220542ANDA091240d2997707-1541-4f5d-8c8d-70b0a13be8b2
12500900053ANDAA-S Medication Solutions Llc2011-11-01INDOMETHACINORALCAPSULE317220542ANDA0912405b05b8bc-4df0-4175-bf53-72129fb21b50
13500900054ANDAA-S Medication Solutions Llc2010-12-22INDOMETHACINORALCAPSULE684620406ANDA0912767755391e-ede3-4a32-854c-736dc6dd2ee3
14500900055ANDAA-S Medication Solutions Llc2010-12-22INDOMETHACINORALCAPSULE684620406ANDA091276175a2d81-0d0f-46a3-aaaa-1732982d85fd
15502680430ANDAAvpak2015-05-19INDOMETHACINORALCAPSULE317220542ANDA091240bcaa0e51-a2fc-cf74-027a-1964e38c5e4e
16510790190NDAMylan Institutional Inc.1998-09-10INDOMETHACINORALCAPSULE003780143NDA0188585647b6ca-5620-4ec4-b364-ce3b8f1e634b
17521250157ANDARemedyrepack Inc.2013-03-26INDOMETHACINORALCAPSULE000934029ANDA070719417d7843-a3ab-4dcd-8b0e-11fae266b41b
18521250438NDARemedyrepack Inc.2013-06-17INDOMETHACINORALCAPSULE231550010NDA0188518280103a-b1c0-4a3c-bc7b-ddd0a1088924
19521250716ANDARemedyrepack Inc.2013-09-26INDOMETHACINORALCAPSULE684620406ANDA0912762768df38-aadd-4151-aae8-b7f221a45071
20548680074NDAPhysicians Total Care, Inc.2004-08-02INDOMETHACINORALCAPSULE003780143NDA01885858ae8e0c-5555-4702-a61f-dde7d396a6db
21551545679NDA AUTHORIZED GENERICCardinal Health2010-10-29INDOMETHACINORALCAPSULE510790190NDA0188583721e946-6f15-43bc-a4ca-aeb3788dac30
22552890147NDAPd-Rx Pharmaceuticals, Inc.2010-09-15INDOMETHACINORALCAPSULE003780143NDA018858549dba03-10c5-4da8-b893-336a6f4ded20
23581184129ANDAClinical Solutions Wholesale2007-12-14INDOMETHACINORALCAPSULE000934029ANDA070719319c7e12-bcbf-447b-9861-92d367a20182
24617860016ANDARemedyrepack Inc.2014-08-26INDOMETHACINORALCAPSULE317220542ANDA0912402f82e669-8c91-4b07-adc4-7d64f0ec657a
25617860351NDARemedyrepack Inc.2015-06-19INDOMETHACINORALCAPSULE231550010NDA018851768c89eb-bf6e-437f-9be4-45a8609467e2
26619190129ANDADirect Rx2014-01-01INDOMETHACINORALCAPSULE317220542ANDA091240aa443877-b407-4ace-b162-9b2a3c89dc93
27631870290NDAProficient Rx Lp2010-07-30INDOMETHACINORALCAPSULE231550010NDA0188516592acb7-129a-404e-b8b6-433ff09c792b
28636291780NDABryant Ranch Prepack2010-07-30INDOMETHACINORALCAPSULE231550010NDA01885197742638-f888-0020-f9a0-088b42a625a0
29670460330NDAContract Pharmacy Services-Pa2010-07-30INDOMETHACINORALCAPSULE003780143NDA0188583d5df05a-f4af-48d8-b880-97dfb92e900c
30672960527ANDARedpharm Drug Inc.2010-07-16INDOMETHACINORALCAPSULE000934029ANDA07071950df5188-358e-4e59-b7d0-1dcec98c2ab0
31687889107NDAPreferred Pharmaceuticals, Inc.2010-07-30INDOMETHACINORALCAPSULE231550010NDA018851d3f12dab-1802-4d6a-9f90-6359e6b24565

indomethacin 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1422110202TivorbexNDAIroko Pharmaceuticals, Llc2015-07-06INDOMETHACINORALCAPSULENDA20476804ca474c-798e-43dd-be7a-1b36720e6a3d

indomethacin 50 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550011NDAHeritage Pharmaceuticals Inc.2010-07-30INDOMETHACINORALCAPSULENDA0188514babe1c2-15f2-40af-b326-b256507a921c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934030ANDATeva Pharmaceuticals Usa Inc2007-12-14INDOMETHACINORALCAPSULEANDA0707566422d983-a063-41ae-aa96-7ae2284cb123
2003780147ANDAMylan Pharmaceuticals Inc.1984-04-20INDOMETHACINORALCAPSULEANDA070624603bc652-31c6-4d50-bb80-e6da5289a3c7
3007812350ANDASandoz Inc1987-04-29INDOMETHACINORALCAPSULEANDA07067457c11bb8-d133-43e2-a74f-838c31296eb5
4317220543ANDACamber Pharmaceuticals, Inc.2011-11-01INDOMETHACINORALCAPSULEANDA0912401ce9c3c5-0cf7-4760-988d-2559adcfb200
5576640120ANDACaraco Pharmaceutical Laboratories, Ltd.2013-05-16INDOMETHACINORALCAPSULEANDA091401c70b5045-706e-443a-9be1-d0bc3c598130
6659775043ANDAHetero Drugs Ltd.,2011-04-12INDOMETHACINORALCAPSULEANDA091240110aada7-dfe8-4ecf-80c7-4dac8907ad29
7684620302ANDAGlenmark Generics Inc., Usa2010-12-22INDOMETHACINORALCAPSULEANDA091276f7ed39e2-5431-4e47-935c-c7441d058f94

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440083ANDABlenheim Pharmacal, Inc.2012-08-13INDOMETHACINORALCAPSULE684620302ANDA091276a9b815a8-5e80-4a54-958c-6c307b87f323
2105440216ANDABlenheim Pharmacal, Inc.2010-11-08INDOMETHACINORALCAPSULE003780147ANDA070624119174f1-af2f-355d-e054-00144ff8d46c
3165900130ANDAStat Rx Usa Llc2010-07-16INDOMETHACINORALCAPSULE00934030ANDA070756d3c9e8ef-422a-4657-a4f9-2a668905515f
4216950523ANDARebel Distributors Corp1986-02-12INDOMETHACINORALCAPSULE000934030ANDA0707564755e174-f5d7-451a-9649-46222a6dfced
5242360621ANDARemedyrepack Inc.2013-03-18INDOMETHACINORALCAPSULE003780147ANDA07062474914fe0-6fe1-433b-80f2-b64fb8bb52e9
6353560697ANDALake Erie Medical Dba Quality Care Products Llc2010-12-22INDOMETHACINORALCAPSULE684620302ANDA091276b5e53529-e370-4916-a23c-8c9d945f971c
7422540081ANDARebel Distributors Corp2010-12-22INDOMETHACINORALCAPSULE684620302ANDA0912769f082d89-d218-49e0-8fcb-0000b5eb04a5
8493490595ANDARemedyrepack Inc.2011-10-25INDOMETHACINORALCAPSULE007812350ANDA070674c149ba5c-4c25-426a-a172-6ac3b899cbe3
9493490776NDARemedyrepack Inc.2011-09-08INDOMETHACINORALCAPSULE231550011NDA018851dfd184f0-2e52-454c-8ef2-3153be7dd4c9
10499990100ANDALake Erie Medical Dba Quality Care Products Llc2011-04-20INDOMETHACINORALCAPSULE000934030ANDA070756564a6f8a-1f80-41e5-90f2-c2f07172130c
11500900050ANDAA-S Medication Solutions Llc2011-11-01INDOMETHACINORALCAPSULE317220543ANDA091240d2997707-1541-4f5d-8c8d-70b0a13be8b2
12500900051ANDAA-S Medication Solutions Llc2011-11-01INDOMETHACINORALCAPSULE317220543ANDA0912405b05b8bc-4df0-4175-bf53-72129fb21b50
13502680431ANDAAvpak2015-05-20INDOMETHACINORALCAPSULE317220543ANDA091240bcaa0e51-a2fc-cf74-027a-1964e38c5e4e
14504360875ANDAUnit Dose Services2011-11-01INDOMETHACINORALCAPSULE317220543ANDA091240cc215f27-8fd5-4625-93ff-8a852d4a652b
15510790191ANDAMylan Institutional Inc.1998-09-15INDOMETHACINORALCAPSULE003780147ANDA0706245647b6ca-5620-4ec4-b364-ce3b8f1e634b
16521250325NDARemedyrepack Inc.2013-05-13INDOMETHACINORALCAPSULE231550011NDA01885171e67d09-0669-473c-8a33-c895803ee510
17521250933ANDARemedyrepack Inc.2014-05-07INDOMETHACINORALCAPSULE317220543ANDA091240cd17444b-88cc-4c7c-9d8b-d90482f73824
18548680875ANDAPhysicians Total Care, Inc.1999-07-27INDOMETHACINORALCAPSULE003780147ANDA07062458ae8e0c-5555-4702-a61f-dde7d396a6db
19552890663ANDAPd-Rx Pharmaceuticals, Inc.2010-09-15INDOMETHACINORALCAPSULE003780147ANDA070624b463cd5f-299a-45f8-a1b3-c9e7fe271955
20581184130ANDAClinical Solutions Wholesale2007-12-14INDOMETHACINORALCAPSULE000934030ANDA070756319c7e12-bcbf-447b-9861-92d367a20182
21619190130ANDADirect Rx2014-01-01INDOMETHACINORALCAPSULE317220543ANDA0912407e7175d7-5e43-4151-9702-88ac2cd44ef6
22619190487NDADirect Rx2015-01-01INDOMETHACINORALCAPSULE231550011NDA01885174099022-892a-46d8-a64e-4a9d7d3256cd
23631870282ANDAProficient Rx Lp2011-11-01INDOMETHACINORALCAPSULE317220543ANDA09124066e3205b-eab1-4864-bf36-116e9d79fe3e
24636291418NDABryant Ranch Prepack2010-07-30INDOMETHACINORALCAPSULE231550011NDA0188511db9d6d7-c53f-5675-5f81-056800ed3875
25661160529ANDAMedvantx, Inc.2007-12-14INDOMETHACINORALCAPSULE000934030ANDA070756877417ef-7706-44cf-a8a7-1fec3e7a0266
26670460331ANDAContract Pharmacy Services-Pa2010-07-30INDOMETHACINORALCAPSULE003780147ANDA0706243d5df05a-f4af-48d8-b880-97dfb92e900c
27672960560NDARedpharm Drug Inc.2007-04-01INDOMETHACINORALCAPSULE007812350NDA0188514077592a-8790-4d45-8cb6-2c95a0a929de
28687889108NDAPreferred Pharmaceuticals, Inc.2010-07-30INDOMETHACINORALCAPSULE231550011NDA018851d3f12dab-1802-4d6a-9f90-6359e6b24565

indomethacin 75 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597460379ANDAJubilant Cadista Pharmaceuticals, Inc.2015-10-05INDOMETHACINORALCAPSULEANDA2027067b61c038-717c-0dee-4cab-d6aa55cbf28a

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drugin other drug docs
1ANDA070067INDOMETHACINTrueMUTUAL PHARMACEUTICAL CO INC1986-10-03ANDA070067_001
2ANDA070068INDOMETHACINTrueMUTUAL PHARMACEUTICAL CO INC1986-10-03ANDA070068_001
3ANDA070266INDO-LEMMONTrueTEVA PHARMACEUTICALS USA INC1985-11-07ANDA070266_001
4ANDA070267INDO-LEMMONTrueTEVA PHARMACEUTICALS USA INC1985-11-07ANDA070267_001
5ANDA070326INDOMETHACINTrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1985-10-18ANDA070326_001
6ANDA070327INDOMETHACINTrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1985-10-18ANDA070327_001
7ANDA070353INDOMETHACINTrueCYCLE PHARMACEUTICALS LTD1985-06-18ANDA070353_001
8ANDA070354INDOMETHACINTrueCYCLE PHARMACEUTICALS LTD1985-06-18ANDA070354_001
9ANDA070487INDOMETHACINTrueSUPERPHARM CORP1986-10-10ANDA070487_001
10ANDA070488INDOMETHACINTrueSUPERPHARM CORP1986-10-10ANDA070488_001
11ANDA070529INDOMETHACINTrueWATSON LABORATORIES INC1985-10-18ANDA070529_001
12ANDA070530INDOMETHACINTrueWATSON LABORATORIES INC1985-10-18ANDA070530_001
13ANDA070592INDOMETHACINTruePIONEER PHARMACEUTICALS INC1986-08-11ANDA070592_001
14ANDA070624INDOMETHACINMYLAN PHARMACEUTICALS INC1985-09-04ANDA070624_001
15ANDA070635INDOMETHACINTrueHALSEY DRUG CO INC1987-06-03ANDA070635_001
16ANDA070651INDOMETHACINTrueVINTAGE PHARMACEUTICALS LLC1986-03-05ANDA070651_001
17ANDA070673INDOMETHACINSANDOZ INC1987-04-29ANDA070673_001
18ANDA070674INDOMETHACINSANDOZ INC1987-04-29ANDA070674_001
19ANDA070719INDOMETHACINIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1986-02-12ANDA070719_001
20ANDA070756INDOMETHACINIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1986-02-12ANDA070756_001
21ANDA070782INDOMETHACINTrueHALSEY DRUG CO INC1987-06-03ANDA070782_001
22ANDA070784INDOMETHACINTrueWATSON LABORATORIES INC1986-08-20ANDA070784_001
23ANDA070785INDOMETHACINTrueWATSON LABORATORIES INC1986-08-20ANDA070785_001
24ANDA070813INDOMETHACINTruePIONEER PHARMACEUTICALS INC1986-08-11ANDA070813_001
25ANDA070899INDOMETHACINTrueMUTUAL PHARMACEUTICAL CO INC1987-02-09ANDA070899_001
26ANDA070900INDOMETHACINTrueMUTUAL PHARMACEUTICAL CO INC1987-02-09ANDA070900_001
27ANDA071148INDOMETHACINTruePLIVA INC1987-03-18ANDA071148_001
28ANDA071149INDOMETHACINTruePLIVA INC1987-03-18ANDA071149_001
29ANDA071342INDOMETHACINTrueTEVA PHARMACEUTICALS USA INC1988-04-18ANDA071342_001
30ANDA071343INDOMETHACINTrueTEVA PHARMACEUTICALS USA INC1988-04-18ANDA071343_001
31ANDA071635INDOMETHACINTrueWATSON LABORATORIES INC1987-05-18ANDA071635_001
32ANDA072410INDOMETHACINTrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC1989-03-15ANDA072410_001Indomethacin Extended Release Oral Capsule
33ANDA072996INDOMETHACINTrueWATSON LABORATORIES INC1991-07-31ANDA072996_001
34ANDA072997INDOMETHACINTrueWATSON LABORATORIES INC1991-07-31ANDA072997_001
35ANDA074464INDOMETHACINSANDOZ INC1998-05-28ANDA074464_001Indomethacin Extended Release Oral Capsule
36ANDA076114INDOMETHACINTrueABLE LABORATORIES INC2002-02-06ANDA076114_001Indomethacin Extended Release Oral Capsule
37ANDA076666INDOMETHACINTrueABLE LABORATORIES INC2003-12-17ANDA076666_001, ANDA076666_002
38ANDA079175INDOMETHACINAVANTHI INC2009-03-06ANDA079175_001Indomethacin Extended Release Oral Capsule
39ANDA090403INDOMETHACINZYDUS PHARMACEUTICALS USA INC2010-11-15ANDA090403_001, ANDA090403_002
40ANDA091240INDOMETHACINHETERO LABS LTD UNIT III2011-04-12ANDA091240_001, ANDA091240_002
41ANDA091276INDOMETHACINGLENMARK GENERICS LTD INDIA2010-12-22ANDA091276_001, ANDA091276_002
42ANDA091401INDOMETHACINSUN PHARMACEUTICAL INDUSTRIES INC2013-03-28ANDA091401_001, ANDA091401_002
43ANDA091549INDOMETHACINAMNEAL PHARMACEUTICALS2010-12-01ANDA091549_001Indomethacin Extended Release Oral Capsule
44ANDA200529INDOMETHACINPADDOCK LABORATORIES LLC2010-11-30ANDA200529_001Indomethacin Extended Release Oral Capsule
45ANDA201807INDOMETHACINHETERO LABS LTD UNIT III2012-09-28ANDA201807_001Indomethacin Extended Release Oral Capsule
46ANDA202139INDOMETHACINMYLAN PHARMACEUTICALS INC2014-03-20ANDA202139_001Indomethacin Extended Release Oral Capsule
47ANDA202572INDOMETHACINWATSON LABORATORIES INC2013-12-09ANDA202572_001Indomethacin Extended Release Oral Capsule
48ANDA202706INDOMETHACINJUBILANT GENERICS LTD2015-10-05ANDA202706_001Indomethacin Extended Release Oral Capsule
49NDA016059INDOCINTrueIROKO PHARMACEUTICALS LLCNDA016059_001, NDA016059_002
50NDA018185INDOCIN SRTrueIROKO PHARMACEUTICALS LLC1982-02-23NDA018185_001Indomethacin Extended Release Oral Capsule
51NDA018690INDOMETHACINTrueWATSON LABORATORIES INC1984-07-31NDA018690_001, NDA018690_002
52NDA018730INDOMETHACINTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1984-05-04NDA018730_001, NDA018730_002
53NDA018806INDOMETHACINTruePARKE DAVIS DIV WARNER LAMBERT CO1984-11-23NDA018806_001, NDA018806_002
54NDA018829INDOMETHACINTrueVINTAGE PHARMACEUTICALS LLC1984-08-06NDA018829_001, NDA018829_002
55NDA018851INDOMETHACINHERITAGE PHARMACEUTICALS INC1984-05-18NDA018851_001, NDA018851_002
56NDA018858INDOMETHACINMYLAN PHARMACEUTICALS INC1984-04-20NDA018858_001, NDA018858_002
57NDA204768TIVORBEXIROKO PHARMACEUTICALS LLC2014-02-24p8734847, SUBSTANCE
p9089471, TREATMENT OF PAIN
p8992982, SUBSTANCE
NEW PRODUCT [2017-02-24]NDA204768_001, NDA204768_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070067_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1986-10-03INDOMETHACIN
2ANDA070068_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1986-10-03INDOMETHACIN
3ANDA070266_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1985-11-07INDO-LEMMON
4ANDA070267_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1985-11-07INDO-LEMMON
5ANDA070326_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1985-10-18INDOMETHACIN
6ANDA070327_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1985-10-18INDOMETHACIN
7ANDA070353_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1985-06-18INDOMETHACIN
8ANDA070354_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1985-06-18INDOMETHACIN
9ANDA070487_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1986-10-10INDOMETHACIN
10ANDA070488_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1986-10-10INDOMETHACIN
11ANDA070529_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1985-10-18INDOMETHACIN
12ANDA070530_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1985-10-18INDOMETHACIN
13ANDA070592_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1986-08-11INDOMETHACIN
14ANDA070624_001RXINDOMETHACIN (50MG)ORALCAPSULETrueAB1985-09-04INDOMETHACIN
15ANDA070635_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1987-06-03INDOMETHACIN
16ANDA070651_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1986-03-05INDOMETHACIN
17ANDA070673_001RXINDOMETHACIN (25MG)ORALCAPSULEFalseAB1987-04-29INDOMETHACIN
18ANDA070674_001RXINDOMETHACIN (50MG)ORALCAPSULEFalseAB1987-04-29INDOMETHACIN
19ANDA070719_001RXINDOMETHACIN (25MG)ORALCAPSULEFalseAB1986-02-12INDOMETHACIN
20ANDA070756_001RXINDOMETHACIN (50MG)ORALCAPSULEFalseAB1986-02-12INDOMETHACIN
21ANDA070782_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1987-06-03INDOMETHACIN
22ANDA070784_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1986-08-20INDOMETHACIN
23ANDA070785_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1986-08-20INDOMETHACIN
24ANDA070813_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1986-08-11INDOMETHACIN
25ANDA070899_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1987-02-09INDOMETHACIN
26ANDA070900_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1987-02-09INDOMETHACIN
27ANDA071148_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1987-03-18INDOMETHACIN
28ANDA071149_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1987-03-18INDOMETHACIN
29ANDA071342_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1988-04-18INDOMETHACIN
30ANDA071343_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1988-04-18INDOMETHACIN
31ANDA071635_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1987-05-18INDOMETHACIN
32ANDA072410_001discontinuedINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalse1989-03-15INDOMETHACIN
33ANDA072996_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1991-07-31INDOMETHACIN
34ANDA072997_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1991-07-31INDOMETHACIN
35ANDA074464_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASETrueAB1998-05-28INDOMETHACIN
36ANDA076114_001discontinuedINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalse2002-02-06INDOMETHACIN
37ANDA076666_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse2003-12-17INDOMETHACIN
38ANDA076666_002discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse2003-12-17INDOMETHACIN
39ANDA079175_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2009-03-06INDOMETHACIN
40ANDA090403_001RXINDOMETHACIN (25MG)ORALCAPSULEFalseAB2010-11-15INDOMETHACIN
41ANDA090403_002RXINDOMETHACIN (50MG)ORALCAPSULEFalseAB2010-11-15INDOMETHACIN
42ANDA091240_001RXINDOMETHACIN (25MG)ORALCAPSULEFalseAB2011-04-12INDOMETHACIN
43ANDA091240_002RXINDOMETHACIN (50MG)ORALCAPSULEFalseAB2011-04-12INDOMETHACIN
44ANDA091276_001RXINDOMETHACIN (25MG)ORALCAPSULEFalseAB2010-12-22INDOMETHACIN
45ANDA091276_002RXINDOMETHACIN (50MG)ORALCAPSULEFalseAB2010-12-22INDOMETHACIN
46ANDA091401_001RXINDOMETHACIN (25MG)ORALCAPSULEFalseAB2013-03-28INDOMETHACIN
47ANDA091401_002RXINDOMETHACIN (50MG)ORALCAPSULEFalseAB2013-03-28INDOMETHACIN
48ANDA091549_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2010-12-01INDOMETHACIN
49ANDA200529_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2010-11-30INDOMETHACIN
50ANDA201807_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2012-09-28INDOMETHACIN
51ANDA202139_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2014-03-20INDOMETHACIN
52ANDA202572_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2013-12-09INDOMETHACIN
53ANDA202706_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2015-10-05INDOMETHACIN
54NDA016059_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalseINDOCIN
55NDA016059_002discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalseINDOCIN
56NDA018185_001discontinuedINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-02-23INDOCIN SR
57NDA018690_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1984-07-31INDOMETHACIN
58NDA018690_002discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1984-07-31INDOMETHACIN
59NDA018730_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1984-05-04INDOMETHACIN
60NDA018730_002discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1984-05-04INDOMETHACIN
61NDA018806_001discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1984-11-23INDOMETHACIN
62NDA018806_002discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1984-11-23INDOMETHACIN
63NDA018829_001discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1984-08-06INDOMETHACIN
64NDA018829_002discontinuedINDOMETHACIN (25MG)ORALCAPSULEFalse1984-08-06INDOMETHACIN
65NDA018851_001RXINDOMETHACIN (25MG)ORALCAPSULEFalseAB1984-05-18INDOMETHACIN
66NDA018851_002RXINDOMETHACIN (50MG)ORALCAPSULEFalseAB1984-05-18INDOMETHACIN
67NDA018858_001RXINDOMETHACIN (25MG)ORALCAPSULEFalseAB1984-04-20INDOMETHACIN
68NDA018858_002discontinuedINDOMETHACIN (50MG)ORALCAPSULEFalse1984-04-20INDOMETHACIN
69NDA204768_001RXINDOMETHACIN (20MG)ORALCAPSULEFalse2014-02-24TIVORBEX
70NDA204768_002RXINDOMETHACIN (40MG)ORALCAPSULETrue2014-02-24TIVORBEX

patent(s)

#idexpiration dateapplication(s)
1p8734847 (view patent)2030-04-23NDA204768
2p8992982 (view patent)2030-04-23NDA204768
3p9089471 (view patent)2030-04-23NDA204768

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104ca474c-798e-43dd-be7a-1b36720e6a3d (view SPL)These highlights do not include all the information needed to use TIVORBEX safely and effectively. See full prescribing information for TIVORBEX. TIVORBEX (indomethacin) Capsules for oral useInitial U.S. Approval: 1965prescriptionHuman PrescriptionIroko Pharmaceuticals, LlcMANUFACTURE2015-06-043422110201, 422110202
2110aada7-dfe8-4ecf-80c7-4dac8907ad29 (view SPL)prescriptionHuman PrescriptionHetero Drugs Ltd.,ANALYSIS, MANUFACTURE2011-05-041659775042, 659775043
3119174f1-af2f-355d-e054-00144ff8d46c (view SPL)prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-181105440216
41193ebb6-26bb-646c-e054-00144ff88e88 (view SPL)prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-182105440234
5175a2d81-0d0f-46a3-aaaa-1732982d85fd (view SPL)Indomethacin Capsules USP, 25 mg and 50 mgprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-171500900055
6197c0496-3910-44ed-b8fb-df01b0f925a8 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-05-12125493490113
71ce9c3c5-0cf7-4760-988d-2559adcfb200 (view SPL)Indomethacin Capsule, USP Rx onlyprescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.MANUFACTURE2011-10-271317220542, 317220543
81db9d6d7-c53f-5675-5f81-056800ed3875 (view SPL)Indomethacin Capsules, USP Rx OnlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-183636291418
91f60d27b-fa95-40dd-969f-51f977142032 (view SPL)Indomethacin Capsules USP, 25 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-05-132216950522
102768df38-aadd-4151-aae8-b7f221a45071 (view SPL)Indomethacin Capsules USP, 25 mg and 50 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-261521250716
112f82e669-8c91-4b07-adc4-7d64f0ec657a (view SPL)Indomethacin Capsule, USP Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2014-08-261617860016
12319c7e12-bcbf-447b-9861-92d367a20182 (view SPL)INDOMETHACIN CAPSULES USP Rx onlyprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2014-07-011581184129, 581184130
133721e946-6f15-43bc-a4ca-aeb3788dac30 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2014-05-194551545679
143d5df05a-f4af-48d8-b880-97dfb92e900c (view SPL)INDOMETHACIN CAPSULES, USPprescriptionHuman PrescriptionContract Pharmacy Services-Pa2010-07-301670460330, 670460331
154077592a-8790-4d45-8cb6-2c95a0a929de (view SPL)Indomethacin CapsulesprescriptionHuman PrescriptionRedpharm Drug Inc.repack2011-07-251672960560
16417d7843-a3ab-4dcd-8b0e-11fae266b41b (view SPL)INDOMETHACIN CAPSULES USP Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-261521250157
174755e174-f5d7-451a-9649-46222a6dfced (view SPL)INDOMETHACIN CAPSULES USP Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-291216950523
184b8dbfb7-5f20-4398-937a-72ed536c57c4 (view SPL)Indomethacin Capsules, USP Rx OnlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-06-131422540237
194babe1c2-15f2-40af-b326-b256507a921c (view SPL)Indomethacin Capsules, USP 01/14- Rev 05 Rx OnlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2014-05-016231550010, 231550011
2050df5188-358e-4e59-b7d0-1dcec98c2ab0 (view SPL)INDOMETHACIN CAPSULES USP Rx onlyprescriptionHuman PrescriptionRedpharm Drug Inc.ANALYSIS, MANUFACTURE2011-07-152672960527
21549dba03-10c5-4da8-b893-336a6f4ded20 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2008-03-135552890147
225647b6ca-5620-4ec4-b364-ce3b8f1e634b (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-02-013510790190, 510790191
23564a6f8a-1f80-41e5-90f2-c2f07172130c (view SPL)INDOMETHACIN CAPSULES USP Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, repack2011-12-133369499990100
24568a1378-6dd4-49a5-a8b8-769972c1e0aa (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2008-03-137003780143
2557c11bb8-d133-43e2-a74f-838c31296eb5 (view SPL)Indomethacin Capsules, USPprescriptionHuman PrescriptionSandoz Inc2012-11-0711007812325, 007812350
2658ae8e0c-5555-4702-a61f-dde7d396a6db (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2008-03-132548680074, 548680875
275b05b8bc-4df0-4175-bf53-72129fb21b50 (view SPL)Indomethacin Capsule, USP Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-171500900051, 500900053
28603bc652-31c6-4d50-bb80-e6da5289a3c7 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-299003780147
296422d983-a063-41ae-aa96-7ae2284cb123 (view SPL)INDOMETHACIN CAPSULES USP Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-1211000934029, 000934030
306592acb7-129a-404e-b8b6-433ff09c792b (view SPL)Indomethacin Capsules, USP01/14- Rev 05 Rx OnlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-03-272631870290
3166e3205b-eab1-4864-bf36-116e9d79fe3e (view SPL)Indomethacin Capsule, USP Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-012631870282
3271e67d09-0669-473c-8a33-c895803ee510 (view SPL)Indomethacin Capsules, USP 04/2011 Rx OnlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-131521250325
3373912f56-94a3-443b-a31a-8a246c411a08 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-03-181242360132
3474099022-892a-46d8-a64e-4a9d7d3256cd (view SPL)INDOMETHACINprescriptionHuman PrescriptionDirect Rxrepack2015-10-211619190487
3574914fe0-6fe1-433b-80f2-b64fb8bb52e9 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-03-181242360621
36768c89eb-bf6e-437f-9be4-45a8609467e2 (view SPL)Indomethacin Capsules, USP 01/14- Rev 05 Rx OnlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-06-192617860351
377755391e-ede3-4a32-854c-736dc6dd2ee3 (view SPL)Indomethacin Capsules USP, 25 mg and 50 mgprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-171500900054
387b61c038-717c-0dee-4cab-d6aa55cbf28a (view SPL)Indomethacin Extended-Release Capsules, USP 75 mg Rx OnlyprescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.MANUFACTURE2015-10-076597460379
397e7175d7-5e43-4151-9702-88ac2cd44ef6 (view SPL)INDOMETHACINprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-05-113619190130
408280103a-b1c0-4a3c-bc7b-ddd0a1088924 (view SPL)Indomethacin Capsules, USP 04/2011 Rx OnlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-171521250438
4185f68421-4773-4d88-a52f-6d07ece4a31f (view SPL)Indomethacin Capsules, USP 01/14- Rev 05 Rx OnlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-05-017430630594
42877417ef-7706-44cf-a8a7-1fec3e7a0266 (view SPL)INDOMETHACIN CAPSULES USP Rx onlyprescriptionHuman PrescriptionMedvantx, Inc.REPACK2012-07-301661160529
4397742638-f888-0020-f9a0-088b42a625a0 (view SPL)Indomethacin Capsules, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636291780
449f082d89-d218-49e0-8fcb-0000b5eb04a5 (view SPL)Indomethacin Capsules USP, 25 mg and 50 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-01-103422540081
45a9b815a8-5e80-4a54-958c-6c307b87f323 (view SPL)Indomethacin Capsules USP, 25 mg and 50 mgprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-07-315105440083
46aa443877-b407-4ace-b162-9b2a3c89dc93 (view SPL)INDOMETHACINprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-07-101619190129
47ad71bdc6-b47f-441c-9d05-279b3d81b975 (view SPL)INDOMETHACIN CAPSULES USP Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-05-201353560876
48b463cd5f-299a-45f8-a1b3-c9e7fe271955 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2008-03-134552890663
49b4cf01d1-0d71-4f0f-97a5-07a59744149f (view SPL)Indomethacin Capsules USP, 25 mg and 50 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-02-233430630368
50b5e53529-e370-4916-a23c-8c9d945f971c (view SPL)Indomethacin Capsules USP, 25 mg and 50 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-07-093911353560697
51b9e8ab78-ae95-4036-b756-84b0d6ef2fac (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-06-091165900129
52bcaa0e51-a2fc-cf74-027a-1964e38c5e4e (view SPL)Indomethacin Capsule, USPRx onlyprescriptionHuman PrescriptionAvpak2015-05-201502680430, 502680431
53c149ba5c-4c25-426a-a172-6ac3b899cbe3 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-10-251493490595
54c70b5045-706e-443a-9be1-d0bc3c598130 (view SPL)prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.ANALYSIS, MANUFACTURE, PACK2013-05-164576640119, 576640120
55cc215f27-8fd5-4625-93ff-8a852d4a652b (view SPL)Indomethacin Capsule, USP Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-10-272504360875
56cd17444b-88cc-4c7c-9d8b-d90482f73824 (view SPL)Indomethacin Capsule, USP Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2014-05-071521250933
57d2997707-1541-4f5d-8c8d-70b0a13be8b2 (view SPL)Indomethacin Capsule, USP Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-171500900050, 500900052
58d3c9e8ef-422a-4657-a4f9-2a668905515f (view SPL)INDOMETHACIN CAPSULES USP Rx onlyprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-06-091165900130
59d3f12dab-1802-4d6a-9f90-6359e6b24565 (view SPL)Indomethacin Capsules, USP01/14- Rev 05 Rx OnlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-01-214687889107, 687889108
60dfd184f0-2e52-454c-8ef2-3153be7dd4c9 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-081493490776
61e3f4420e-0052-4dbd-bb4b-7e7b76dc71ea (view SPL)INDOMETHACIN 25 MG 30 CAPS FOR MYLANprescriptionHuman PrescriptionLiberty Pharmaceuticals, Inc.2013-09-251004401652
62f7ed39e2-5431-4e47-935c-c7441d058f94 (view SPL)Indomethacin Capsules USP, 25 mg and 50 mgprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-07-284684620302, 684620406

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII