Disulfiram Oral Tablet

Brand(s)
Antabuse
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2014-11-04)
Oldest Current Product
2000-12-01
License(s)
ANDA
RxNORM
ORAL TABLET\DISULFIRAM
FDAOB
ORAL\TABLET\DISULFIRAM
SPL Active
ORAL\TABLET\DISULFIRAM
SPL Moiety
ORAL\TABLET\DISULFIRAM

product(s) by strength(s)

disulfiram 250 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540356ANDARoxane Laboratories, Inc2014-11-04DISULFIRAMORALTABLETANDA202652719b12b2-061b-4893-b888-34191e45bc57
2000935035ANDATeva Pharmaceuticals Usa Inc2011-04-15DISULFIRAMORALTABLETANDA088482a49396ee-da77-42df-b94c-130d2fb3dfbc
3003784140ANDAMylan Pharmaceuticals Inc.2015-03-04DISULFIRAMORALTABLETANDA203916d2361d16-94fc-43a9-8009-ed03dce0544f
4006033433ANDAQualitest Pharmaceuticals2012-12-31DISULFIRAMORALTABLETANDA09156306b00003-a94f-4fe8-808c-e6e101b06ebe
5477810607ANDAAlvogen, Inc.2012-08-31DISULFIRAMORALTABLETANDA091681b90f8ff4-4fb3-46ab-8149-cb55f24a4044
6512850523AntabuseANDATeva Women'S Health, Inc.2000-12-01DISULFIRAMORALTABLETANDA088482f0ca0e1f-9641-48d5-9367-e5d1069e8680
7649800171ANDARising Pharmaceuticals, Inc.2011-04-01DISULFIRAMORALTABLETANDA0916197b1531be-7282-4577-89f6-67275ef19978

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685034AntabuseANDAPhysicians Total Care, Inc.2004-03-30DISULFIRAMORALTABLET512850523ANDA08848212850de3-c97c-42c1-b8d3-55dc6fd05750
2604290196ANDAGolden State Medical Supply, Inc.2013-09-11DISULFIRAMORALTABLET477810607ANDA091681d3832a1a-a140-49c1-a7df-134fa81341e3
3681512694ANDACarilion Materials Management2011-04-01DISULFIRAMORALTABLET649800171ANDA09161935f34124-7300-4b96-911f-d9f03016ea14

disulfiram 500 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540357ANDARoxane Laboratories, Inc2014-11-04DISULFIRAMORALTABLETANDA202652719b12b2-061b-4893-b888-34191e45bc57
2000935036ANDATeva Pharmaceuticals Usa Inc2011-07-19DISULFIRAMORALTABLETANDA088483a49396ee-da77-42df-b94c-130d2fb3dfbc
3003784141ANDAMylan Pharmaceuticals Inc.2015-03-04DISULFIRAMORALTABLETANDA203916d2361d16-94fc-43a9-8009-ed03dce0544f
4006033432ANDAQualitest Pharmaceuticals2012-12-31DISULFIRAMORALTABLETANDA09156306b00003-a94f-4fe8-808c-e6e101b06ebe
5512850524AntabuseANDATeva Women'S Health, Inc.2006-02-01DISULFIRAMORALTABLETANDA088483f0ca0e1f-9641-48d5-9367-e5d1069e8680
6649800172ANDARising Pharmaceuticals, Inc.2011-04-01DISULFIRAMORALTABLETANDA0916197b1531be-7282-4577-89f6-67275ef19978

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA086889DISULFIRAMTrueWATSON LABORATORIES INCANDA086889_001
2ANDA086890DISULFIRAMTrueWATSON LABORATORIES INCANDA086890_001
3ANDA087973DISULFIRAMTrueWATSON LABORATORIES INC1983-08-05ANDA087973_001
4ANDA087974DISULFIRAMTrueWATSON LABORATORIES INC1983-08-05ANDA087974_001
5ANDA088482ANTABUSEODYSSEY PHARMACEUTICALS INC1983-12-08ANDA088482_001
6ANDA088483ANTABUSEODYSSEY PHARMACEUTICALS INC1983-12-08ANDA088483_001
7ANDA088792DISULFIRAMTruePAR PHARMACEUTICAL INC1984-08-14ANDA088792_001
8ANDA088793DISULFIRAMTruePAR PHARMACEUTICAL INC1984-08-14ANDA088793_001
9ANDA091563DISULFIRAMVINTAGE PHARMACEUTICALS2012-12-31ANDA091563_001, ANDA091563_002
10ANDA091619DISULFIRAMSIGMAPHARM LABORATORIES LLC2011-03-28ANDA091619_001, ANDA091619_002
11ANDA091681DISULFIRAM ALVOGEN PINE BROOK INC2013-08-08ANDA091681_001
12ANDA202652DISULFIRAMROXANE LABORATORIES INC2014-02-05ANDA202652_001, ANDA202652_002
13ANDA203916DISULFIRAMMYLAN PHARMACEUTICALS INC2015-03-04ANDA203916_001, ANDA203916_002
14NDA007883ANTABUSETrueTEVA WOMENS HEALTH INCNDA007883_002, NDA007883_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA086889_001discontinuedDISULFIRAM (250MG)ORALTABLETFalseDISULFIRAM
2ANDA086890_001discontinuedDISULFIRAM (500MG)ORALTABLETFalseDISULFIRAM
3ANDA087973_001discontinuedDISULFIRAM (250MG)ORALTABLETFalse1983-08-05DISULFIRAM
4ANDA087974_001discontinuedDISULFIRAM (500MG)ORALTABLETFalse1983-08-05DISULFIRAM
5ANDA088482_001RXDISULFIRAM (250MG)ORALTABLETFalseAB1983-12-08ANTABUSE
6ANDA088483_001RXDISULFIRAM (500MG)ORALTABLETTrueAB1983-12-08ANTABUSE
7ANDA088792_001discontinuedDISULFIRAM (250MG)ORALTABLETFalse1984-08-14DISULFIRAM
8ANDA088793_001discontinuedDISULFIRAM (500MG)ORALTABLETFalse1984-08-14DISULFIRAM
9ANDA091563_001RXDISULFIRAM (250MG)ORALTABLETFalseAB2012-12-31DISULFIRAM
10ANDA091563_002RXDISULFIRAM (500MG)ORALTABLETFalseAB2012-12-31DISULFIRAM
11ANDA091619_001RXDISULFIRAM (250MG)ORALTABLETFalseAB2011-03-28DISULFIRAM
12ANDA091619_002RXDISULFIRAM (500MG)ORALTABLETFalseAB2011-03-28DISULFIRAM
13ANDA091681_001RXDISULFIRAM (250MG)ORALTABLETFalseAB2013-08-08DISULFIRAM
14ANDA202652_001RXDISULFIRAM (250MG)ORALTABLETFalseAB2014-02-05DISULFIRAM
15ANDA202652_002RXDISULFIRAM (500MG)ORALTABLETFalseAB2014-02-05DISULFIRAM
16ANDA203916_001RXDISULFIRAM (250MG)ORALTABLETFalseAB2015-03-04DISULFIRAM
17ANDA203916_002RXDISULFIRAM (500MG)ORALTABLETFalseAB2015-03-04DISULFIRAM
18NDA007883_002discontinuedDISULFIRAM (500MG)ORALTABLETFalseANTABUSE
19NDA007883_003discontinuedDISULFIRAM (250MG)ORALTABLETFalseANTABUSE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
106b00003-a94f-4fe8-808c-e6e101b06ebe (view SPL)DISULFIRAM TABLETS USP IN ALCOHOLISM 250 mg and 500 mg Rx onlyprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2013-01-022006033432, 006033433
212850de3-c97c-42c1-b8d3-55dc6fd05750 (view SPL)ANTABUSE(Disulfiram Tablets USP)IN ALCOHOLISMprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-04-181548685034
335f34124-7300-4b96-911f-d9f03016ea14 (view SPL)Disulfiram Tablets, USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-12-302681512694
4719b12b2-061b-4893-b888-34191e45bc57 (view SPL)Disulfiram Tablets, USPprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-11-041000540356, 000540357
57b1531be-7282-4577-89f6-67275ef19978 (view SPL)Disulfiram Tablets, USPprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.api/fdf analytical testing, manufacture2013-12-303649800171, 649800172
6a49396ee-da77-42df-b94c-130d2fb3dfbc (view SPL)DISULFIRAM TABLETS USPIN ALCOHOLISMprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-12-106000935035, 000935036
7b90f8ff4-4fb3-46ab-8149-cb55f24a4044 (view SPL)Disulfiram Tablets, USPIN ALCOHOLISM Rx OnlyprescriptionHuman PrescriptionAlvogen, Inc.ANALYSIS, MANUFACTURE2012-08-315477810607
8d2361d16-94fc-43a9-8009-ed03dce0544f (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-09-183003784140, 003784141
9d3832a1a-a140-49c1-a7df-134fa81341e3 (view SPL)Disulfiram Tablets USP, 250 mgprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-10-231604290196
10f0ca0e1f-9641-48d5-9367-e5d1069e8680 (view SPL)Antabuse (disulfiram tablets USP)IN ALCOHOLISMprescriptionHuman PrescriptionTeva Women'S Health, Inc.2014-08-018512850523, 512850524

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