Rifampin Oral Capsule

Brand(s)
Rifadin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2014-06-12)
Oldest Current Product
1971-05-21
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\RIFAMPIN
FDAOB
ORAL\CAPSULE\RIFAMPIN
SPL Active
ORAL\CAPSULE, COATED\RIFAMPIN
ORAL\CAPSULE\RIFAMPIN
SPL Moiety
ORAL\CAPSULE, COATED\RIFAMPIN
ORAL\CAPSULE\RIFAMPIN

product(s) by strength(s)

rifampin 150 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680510RifadinANDASanofi-Aventis U.S. Llc1981-07-15RIFAMPINORALCAPSULEANDA062303036ab68e-5085-4edc-bd83-784b43d64eab
2001850801ANDAEon Labs, Inc.1998-01-02RIFAMPINORALCAPSULEANDA06415055816042-946d-4bec-9461-bd998628ff45
3005271393ANDALannett Company, Inc.2008-04-20RIFAMPINORALCAPSULEANDA06539085532a0e-24fa-4a4f-9a0e-721502fa7d7e
4617480015ANDAVersapharm Incorporated2001-07-01RIFAMPINORALCAPSULEANDA06502826a2dbca-5090-4f6c-99ed-e11a70bb5af0
5681800658ANDALupin Pharmaceuticals, Inc.2013-10-28RIFAMPINORALCAPSULEANDA090034b56004f0-f23d-47f6-80c7-39884fccbccc

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490311ANDARemedyrepack Inc.2011-06-20RIFAMPINORALCAPSULE001850801ANDA0641501f641c0d-ccca-44da-85dd-3d88d1efffa7
2493490447ANDARemedyrepack Inc.2011-08-03RIFAMPINORALCAPSULE001850801ANDA064150eac3e17d-aac3-482b-98a0-c2258255d180
3548685472ANDAPhysicians Total Care, Inc.2008-04-20RIFAMPINORALCAPSULE005271393ANDA0653909498a2f4-6b05-4811-80d7-9acaa9cf59a5
4680840357ANDAAmerican Health Packaging2009-09-25RIFAMPINORALCAPSULE005271393ANDA065390a086ceb6-7796-437f-865d-e25b39bd1a23

rifampin 300 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680508RifadinNDASanofi-Aventis U.S. Llc1971-05-21RIFAMPINORALCAPSULENDA050420036ab68e-5085-4edc-bd83-784b43d64eab

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850799ANDAEon Labs, Inc.1997-05-28RIFAMPINORALCAPSULEANDA06415055816042-946d-4bec-9461-bd998628ff45
2005271315ANDALannett Company, Inc.2008-04-20RIFAMPINORALCAPSULEANDA06539085532a0e-24fa-4a4f-9a0e-721502fa7d7e
3617480018ANDAVersapharm Incorporated2001-07-01RIFAMPINORALCAPSULEANDA06502826a2dbca-5090-4f6c-99ed-e11a70bb5af0

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009045282ANDAMajor2009-10-07RIFAMPINORALCAPSULE001850799ANDA0641500a99a222-580b-4d80-8aaf-1c74d9a6caab
2216950527ANDARebel Distributors Corp1997-05-28RIFAMPINORALCAPSULE001850799ANDA06415078c4d20c-9d9b-4f26-bc11-ff193c6c53ca
3242360202ANDARemedyrepack Inc.2013-10-29RIFAMPINORALCAPSULE, COATED617480018ANDA065028e836a96d-6512-46ba-a5dd-776e55abd091
4422540039ANDARebel Distributors Corp2008-04-20RIFAMPINORALCAPSULE005271315ANDA065390d7131853-8850-45bd-9227-c4b1916dd28d
5493490250ANDARemedyrepack Inc.2011-03-28RIFAMPINORALCAPSULE001850799ANDA0641506d9d13e6-246c-435c-b8c2-823eac283463
6510790890ANDAMylan Institutional Inc.1999-12-15RIFAMPINORALCAPSULE001850799ANDA064150363d2275-fca2-4c6d-940c-137e89d9d78c
7529590653ANDAH.J. Harkins Company, Inc.2001-07-01RIFAMPINORALCAPSULE, COATED617480018ANDA0650283cc0bcd2-37d7-4a7b-808b-980d864281af
8538080559ANDAState Of Florida Doh Central Pharmacy2009-07-01RIFAMPINORALCAPSULE, COATED617480018ANDA065028eef30745-075c-4430-8271-2c3f353f40a2
9548684683ANDAPhysicians Total Care, Inc.2008-04-20RIFAMPINORALCAPSULE005271315ANDA0653909498a2f4-6b05-4811-80d7-9acaa9cf59a5
10551545351ANDACardinal Health2011-05-20RIFAMPINORALCAPSULE510790890ANDA064150b58b9f95-6886-40a9-a443-ad95eebebcf0
11551546526ANDACardinal Health2001-03-14RIFAMPINORALCAPSULE, COATED617480018ANDA065028540eaf0a-da8d-41ce-b9c5-0c4e0733a179
12581180008ANDAClinical Solutions Wholesale2008-04-20RIFAMPINORALCAPSULE005271315ANDA065390e52eefd3-1b52-4986-be3b-426a0695e661
13636294042ANDABryant Ranch Prepack1997-05-28RIFAMPINORALCAPSULE001850799ANDA0641500609253c-505b-c6d0-241e-90ffdba25ca2
14637390415ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2006-11-30RIFAMPINORALCAPSULE001850799ANDA06415036579a56-4555-4211-93c5-bb7d9a729b01
15680840358ANDAAmerican Health Packaging2009-09-25RIFAMPINORALCAPSULE005271315ANDA065390a086ceb6-7796-437f-865d-e25b39bd1a23
16681510985ANDACarilion Materials Management2001-07-01RIFAMPINORALCAPSULE, COATED617480018ANDA0650284ca272ce-2781-4ead-82d2-e7c404533a41

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA062303RIFADINSANOFI AVENTIS US LLCANDA062303_001
2ANDA064150RIFAMPINSANDOZ INC1997-05-28ANDA064150_001, ANDA064150_002
3ANDA065028RIFAMPINVERSAPHARM INC2001-03-14ANDA065028_001, ANDA065028_002
4ANDA065390RIFAMPINLANNETT HOLDINGS INC2008-03-28ANDA065390_001, ANDA065390_002
5ANDA090034RIFAMPINLUPIN PHARMACEUTICALS INC2013-08-21ANDA090034_001, ANDA090034_002
6NDA050420RIFADINSANOFI AVENTIS US LLCNDA050420_001
7NDA050429RIMACTANEPROSAM LABS LLCNDA050429_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062303_001RXRIFAMPIN (150MG)ORALCAPSULEFalseABRIFADIN
2ANDA064150_001RXRIFAMPIN (300MG)ORALCAPSULEFalseAB1997-05-28RIFAMPIN
3ANDA064150_002RXRIFAMPIN (150MG)ORALCAPSULEFalseAB1998-01-02RIFAMPIN
4ANDA065028_001RXRIFAMPIN (150MG)ORALCAPSULEFalseAB2001-03-14RIFAMPIN
5ANDA065028_002RXRIFAMPIN (300MG)ORALCAPSULEFalseAB2001-03-14RIFAMPIN
6ANDA065390_001RXRIFAMPIN (150MG)ORALCAPSULEFalseAB2008-03-28RIFAMPIN
7ANDA065390_002RXRIFAMPIN (300MG)ORALCAPSULEFalseAB2008-03-28RIFAMPIN
8ANDA090034_001RXRIFAMPIN (150MG)ORALCAPSULEFalseAB2013-08-21RIFAMPIN
9ANDA090034_002RXRIFAMPIN (300MG)ORALCAPSULEFalseAB2013-08-21RIFAMPIN
10NDA050420_001RXRIFAMPIN (300MG)ORALCAPSULETrueABRIFADIN
11NDA050429_001RXRIFAMPIN (300MG)ORALCAPSULEFalseABRIMACTANE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1036ab68e-5085-4edc-bd83-784b43d64eab (view SPL)RIFADIN (rifampin capsules USP) and RIFADIN IV (rifampin for injection USP)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-06-129000680508, 000680510, 000680597Rifampin Injectable Solution
20609253c-505b-c6d0-241e-90ffdba25ca2 (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK1998-01-022636294042
30a99a222-580b-4d80-8aaf-1c74d9a6caab (view SPL)RIFAMPIN Capsules, USPprescriptionHuman PrescriptionMajor2012-08-305009045282
41f641c0d-ccca-44da-85dd-3d88d1efffa7 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-06-201493490311
526a2dbca-5090-4f6c-99ed-e11a70bb5af0 (view SPL)RIFAMPIN CAPSULES, USPprescriptionHuman PrescriptionVersapharm IncorporatedANALYSIS, MANUFACTURE, PACK2014-11-054617480015, 617480018
6363d2275-fca2-4c6d-940c-137e89d9d78c (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionMylan Institutional Inc.2015-04-034510790890
736579a56-4555-4211-93c5-bb7d9a729b01 (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2013-07-301637390415
83cc0bcd2-37d7-4a7b-808b-980d864281af (view SPL)RIFAMPIN CAPSULES, USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-01-192529590653
94ca272ce-2781-4ead-82d2-e7c404533a41 (view SPL)RIFAMPIN CAPSULES, USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-08-042681510985
10540eaf0a-da8d-41ce-b9c5-0c4e0733a179 (view SPL)RIFAMPIN CAPSULES, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-203551546526
1155816042-946d-4bec-9461-bd998628ff45 (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionEon Labs, Inc.2014-02-036001850799, 001850801
126d9d13e6-246c-435c-b8c2-823eac283463 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-03-281493490250
1378c4d20c-9d9b-4f26-bc11-ff193c6c53ca (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-272216950527
1485532a0e-24fa-4a4f-9a0e-721502fa7d7e (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-07-2418005271315, 005271393
159498a2f4-6b05-4811-80d7-9acaa9cf59a5 (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-01-171548684683, 548685472
16a086ceb6-7796-437f-865d-e25b39bd1a23 (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-266680840357, 680840358
17b56004f0-f23d-47f6-80c7-39884fccbccc (view SPL)Rifampin Capsules USPprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2013-08-303681800658
18b58b9f95-6886-40a9-a443-ad95eebebcf0 (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-203551545351
19d7131853-8850-45bd-9227-c4b1916dd28d (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-131422540039
20e52eefd3-1b52-4986-be3b-426a0695e661 (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionClinical Solutions Wholesalerepack2015-08-052581180008
21e836a96d-6512-46ba-a5dd-776e55abd091 (view SPL)RIFAMPIN CAPSULES, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-10-291242360202
22eac3e17d-aac3-482b-98a0-c2258255d180 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-031493490447
23eef30745-075c-4430-8271-2c3f353f40a2 (view SPL)Rifampin Capsules, USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-011538080559

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