Indomethacin Extended Release Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eon Labs, Inc. (2015-07-22)
Oldest Current Product
1995-04-26
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\INDOMETHACIN
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\INDOMETHACIN
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\INDOMETHACIN
ORAL\CAPSULE\INDOMETHACIN
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\INDOMETHACIN
ORAL\CAPSULE\INDOMETHACIN

product(s) by strength(s)

indomethacin 75 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850720ANDAEon Labs, Inc.1998-05-28INDOMETHACINORALCAPSULE, EXTENDED RELEASEANDA074464d9344dbc-57a8-4fca-bb26-f36a12bf17d4
2005740193ANDAPaddock Laboratories, Llc2010-11-30INDOMETHACINORALCAPSULE, EXTENDED RELEASEANDA2005293ea8f628-53f5-41f7-aad3-10ab7d11fd3a
3107020016ANDAKvk-Tech, Inc.2012-07-27INDOMETHACINORALCAPSULE, EXTENDED RELEASEANDA079175dc80228c-acae-44dc-9762-19bd1669bf45
4317220565ANDACamber Pharmaceuticals, Inc.2012-09-28INDOMETHACINORALCAPSULE, EXTENDED RELEASEANDA20180712f62bae-5fc0-4f8d-a8b4-446524bd53d1
5459630811ANDAActavis Inc.2013-12-17INDOMETHACINORALCAPSULE, EXTENDED RELEASEANDA202572d470bb9f-960c-4782-a96b-e7eff6b14670
6651620506ANDAAmneal Pharmaceuticals2010-12-06INDOMETHACINORALCAPSULE, EXTENDED RELEASEANDA091549dbad7e61-2347-43b1-a422-9183e41c10ea

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440919ANDABlenheim Pharmacal, Inc.2015-06-01INDOMETHACINORALCAPSULE, EXTENDED RELEASE651620506ANDA09154917c9214f-0eba-0088-e054-00144ff88e88
2105440935ANDABlenheim Pharmacal, Inc.2015-07-14INDOMETHACINORALCAPSULE, EXTENDED RELEASE317220565ANDA2018071b8ee98e-3905-0c53-e054-00144ff8d46c
3126340160ANDAApotheca, Inc2010-03-04INDOMETHACINORALCAPSULE107020016ANDA0791756569dfd1-0164-4241-b508-ccd540d1e858
4126340838ANDAApotheca, Inc2006-05-02INDOMETHACINORALCAPSULE001850720ANDA0744646569dfd1-0164-4241-b508-ccd540d1e858
5493490873ANDARemedyrepack Inc.2012-03-01, 2013-12-05, 2013-12-11INDOMETHACINORALCAPSULE, EXTENDED RELEASE651620506ANDA09154941f58ecc-abce-46cc-b18d-1acea74cfa39, a7789269-28a0-4058-848d-9f014db12c6d, ca36d1da-661a-49b8-87bd-31be1b965929
6499990371ANDALake Erie Medical Dba Quality Care Products Llc2011-11-21INDOMETHACINORALCAPSULE, EXTENDED RELEASE651620506ANDA091549570faaad-3e3e-4b89-9f9a-37c90c20a5d9
7502680432ANDAAvpak2015-09-15INDOMETHACINORALCAPSULE, EXTENDED RELEASE317220565ANDA20180733e16ca2-c857-8334-56d7-4e145122c09b
8545691518ANDAA-S Medication Solutions Llc2012-07-27INDOMETHACINORALCAPSULE, EXTENDED RELEASE107020016ANDA0791758df87c64-32fd-4764-9596-4ec406db7f6d
9548680922ANDAPhysicians Total Care, Inc.1995-04-26INDOMETHACINORALCAPSULE001850720ANDA0744645e211b18-8cdc-42ab-8756-4ce2dd94925c
10552890469ANDAPd-Rx Pharmaceuticals, Inc.2012-07-27INDOMETHACINORALCAPSULE, EXTENDED RELEASE107020016ANDA07917585014b51-1354-4d16-9995-3ee33a7155fa
11617860459ANDARemedyrepack Inc.2015-10-28, 2015-11-17INDOMETHACINORALCAPSULE, EXTENDED RELEASE317220565ANDA201807c66fdef5-0d39-4dad-9814-0b61116cc47a, c8a7db96-4008-41dc-a04d-72e9389c3edb
12619190344ANDADirect Rx2015-01-01INDOMETHACINORALCAPSULE, EXTENDED RELEASE317220565ANDA201807ef9444e9-fc20-4139-ae74-ae9268e44a21
13636293201ANDABryant Ranch Prepack2010-12-06INDOMETHACINORALCAPSULE, EXTENDED RELEASE651620506ANDA091549c7eb8830-21c0-6e63-3e3a-c13de600faee
14663360687ANDADispensing Solutions, Inc.2010-12-06INDOMETHACINORALCAPSULE, EXTENDED RELEASE651620506ANDA09154929a6b41c-accb-4b12-92d1-cda19c2148a5
15680840411ANDAAmerican Health Packaging2010-03-26INDOMETHACINORALCAPSULE, EXTENDED RELEASE107020016ANDA0791755a65b650-ea9b-4d0d-b62f-5971df1e62b4
16683870345ANDAKeltman Pharmaceuticals Inc.2006-01-09INDOMETHACINORALCAPSULE001850720ANDA0744643125cb9f-d00c-47e7-9927-fbe38cadb48b

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA072410INDOMETHACINTrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INC1989-03-15ANDA072410_001Indomethacin Oral Capsule
2ANDA074464INDOMETHACINSANDOZ INC1998-05-28ANDA074464_001Indomethacin Oral Capsule
3ANDA076114INDOMETHACINTrueABLE LABORATORIES INC2002-02-06ANDA076114_001Indomethacin Oral Capsule
4ANDA079175INDOMETHACINAVANTHI INC2009-03-06ANDA079175_001Indomethacin Oral Capsule
5ANDA091549INDOMETHACINAMNEAL PHARMACEUTICALS2010-12-01ANDA091549_001Indomethacin Oral Capsule
6ANDA200529INDOMETHACINPADDOCK LABORATORIES LLC2010-11-30ANDA200529_001Indomethacin Oral Capsule
7ANDA201807INDOMETHACINHETERO LABS LTD UNIT III2012-09-28ANDA201807_001Indomethacin Oral Capsule
8ANDA202139INDOMETHACINMYLAN PHARMACEUTICALS INC2014-03-20ANDA202139_001Indomethacin Oral Capsule
9ANDA202572INDOMETHACINWATSON LABORATORIES INC2013-12-09ANDA202572_001Indomethacin Oral Capsule
10ANDA202706INDOMETHACINJUBILANT GENERICS LTD2015-10-05ANDA202706_001Indomethacin Oral Capsule
11NDA018185INDOCIN SRTrueIROKO PHARMACEUTICALS LLC1982-02-23NDA018185_001Indomethacin Oral Capsule

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA072410_001discontinuedINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalse1989-03-15INDOMETHACIN
2ANDA074464_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASETrueAB1998-05-28INDOMETHACIN
3ANDA076114_001discontinuedINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalse2002-02-06INDOMETHACIN
4ANDA079175_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2009-03-06INDOMETHACIN
5ANDA091549_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2010-12-01INDOMETHACIN
6ANDA200529_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2010-11-30INDOMETHACIN
7ANDA201807_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2012-09-28INDOMETHACIN
8ANDA202139_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2014-03-20INDOMETHACIN
9ANDA202572_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2013-12-09INDOMETHACIN
10ANDA202706_001RXINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalseAB2015-10-05INDOMETHACIN
11NDA018185_001discontinuedINDOMETHACIN (75MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-02-23INDOCIN SR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
112f62bae-5fc0-4f8d-a8b4-446524bd53d1 (view SPL)Indomethacin Extended Release Capsules, USPRx onlyprescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2012-10-081317220565
217c9214f-0eba-0088-e054-00144ff88e88 (view SPL)Indomethacin Extended Release Capsules, USP 75 mgprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-06-055105440919
31b8ee98e-3905-0c53-e054-00144ff8d46c (view SPL)Indomethacin Extended Release Capsules, USPRx onlyprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-10-262105440935
429a6b41c-accb-4b12-92d1-cda19c2148a5 (view SPL)Indomethacin Extended Release Capsules, USP 75 mgprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-09-221663360687
53125cb9f-d00c-47e7-9927-fbe38cadb48b (view SPL)Indomethacin Extended-Release Capsules USPprescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.repack2010-07-122683870345
633e16ca2-c857-8334-56d7-4e145122c09b (view SPL)prescriptionHuman PrescriptionAvpak2015-09-283502680432
73ea8f628-53f5-41f7-aad3-10ab7d11fd3a (view SPL)Indomethacin Extended-Release Capsules USP, 75 mg Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2015-08-188005740193
841f58ecc-abce-46cc-b18d-1acea74cfa39 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-011493490873
9570faaad-3e3e-4b89-9f9a-37c90c20a5d9 (view SPL)Indomethacin Extended Release Capsules, USP 75 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcANALYSIS, LABEL, MANUFACTURE, PACK, relabel, repack2011-11-213231499990371
105a65b650-ea9b-4d0d-b62f-5971df1e62b4 (view SPL)INDOMETHACIN EXTENDED-RELEASE CAPSULES USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-113680840411
115e211b18-8cdc-42ab-8756-4ce2dd94925c (view SPL)Indomethacin Extended-Release Capsules USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-04-121548680922
126569dfd1-0164-4241-b508-ccd540d1e858 (view SPL)INDOMETHACIN EXTENDED RELEASE CAPSULES 75MG USPprescriptionHuman PrescriptionApotheca, Increlabel, repack2010-04-162126340160, 126340838
1385014b51-1354-4d16-9995-3ee33a7155fa (view SPL)INDOMETHACIN EXTENDED-RELEASE CAPSULES USP 75 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-07-272552890469
148df87c64-32fd-4764-9596-4ec406db7f6d (view SPL)INDOMETHACIN EXTENDED-RELEASE CAPSULES USP 75 mgprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-291545691518
15a7789269-28a0-4058-848d-9f014db12c6d (view SPL)Indomethacin Extended Release Capsules, USP 75 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-114493490873
16c66fdef5-0d39-4dad-9814-0b61116cc47a (view SPL)Indomethacin Extended Release Capsules, USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-10-281617860459
17c7eb8830-21c0-6e63-3e3a-c13de600faee (view SPL)Indomethacin Extended Release Capsules, USP 75 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-283636293201
18c8a7db96-4008-41dc-a04d-72e9389c3edb (view SPL)Indomethacin Extended Release Capsules, USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-11-171617860459
19ca36d1da-661a-49b8-87bd-31be1b965929 (view SPL)Indomethacin Extended Release Capsules, USP 75 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-052493490873
20d470bb9f-960c-4782-a96b-e7eff6b14670 (view SPL)Indomethacin Extended-Release Capsules, USPprescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, PACK2013-12-184459630811
21d9344dbc-57a8-4fca-bb26-f36a12bf17d4 (view SPL)Indomethacin Extended-Release Capsules USPprescriptionHuman PrescriptionEon Labs, Inc.2015-07-227001850720
22dbad7e61-2347-43b1-a422-9183e41c10ea (view SPL)Indomethacin Extended release Capsules, USP 75 mg Rx onlyprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-07-247651620506
23dc80228c-acae-44dc-9762-19bd1669bf45 (view SPL)INDOMETHACIN EXTENDED-RELEASE CAPSULES USP 75 mgprescriptionHuman PrescriptionKvk-Tech, Inc.MANUFACTURE2012-07-271107020016
24ef9444e9-fc20-4139-ae74-ae9268e44a21 (view SPL)INDOMETHACINprescriptionHuman PrescriptionDirect Rxrepack2015-07-021619190344

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