Azathioprine Oral Tablet

Brand(s)
Azasan, Imuran
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Prometheus Laboratories Inc. (2014-01-01)
Oldest Current Product
1968-03-20
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\AZATHIOPRINE
FDAOB
ORAL\TABLET\AZATHIOPRINE
SPL Active
ORAL\TABLET\AZATHIOPRINE
SPL Moiety
ORAL\TABLET\AZATHIOPRINE

product(s) by strength(s)

azathioprine 100 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1656490241AzasanANDASalix Pharmaceuticals, Inc.2003-04-01AZATHIOPRINEORALTABLETANDA0752529050af7a-19c6-4670-937a-9445605de995

azathioprine 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1654830590ImuranNDAPrometheus Laboratories Inc.1968-03-20AZATHIOPRINEORALTABLETNDA016324aaa6c540-4c84-48a0-939c-cd423134fa2a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544084ANDARoxane Laboratories, Inc1996-02-16AZATHIOPRINEORALTABLETANDA074069aeab212e-2f56-498d-a286-400ba360a7d2
2000548084ANDARoxane Laboratories, Inc1996-02-16AZATHIOPRINEORALTABLETANDA074069aeab212e-2f56-498d-a286-400ba360a7d2
3003781005ANDAMylan Pharmaceuticals Inc.2009-12-28AZATHIOPRINEORALTABLETANDA0755680a83e716-b688-433f-ac27-ae95132810cf
4510790620ANDAMylan Institutional Inc.2010-07-23AZATHIOPRINEORALTABLETANDA075568e385894f-212b-4582-a63a-a0767fd97645
5658410602ANDACadila Healthcare Limited2007-07-11AZATHIOPRINEORALTABLETANDA077621d65bc662-2ae8-4ddb-acc8-f616e72e6140
6683820003ANDAZydus Pharmaceuticals (Usa) Inc.2007-07-11AZATHIOPRINEORALTABLETANDA077621b1b0fa3e-11c3-46d0-9537-6b372c2a1b56
7684620502ANDAGlenmark Generics Inc., Usa1999-08-01AZATHIOPRINEORALTABLETANDA075252200ce996-da00-5be7-e054-00144ff8d46c
8692381076ANDAAmneal Pharmaceuticals Of New York, Llc2015-02-02AZATHIOPRINEORALTABLETANDA074069c49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157568ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1996-02-16AZATHIOPRINEORALTABLET000544084ANDA0740690b383e60-5353-4231-af66-b639a3b2f02c
2216950484ANDARebel Distributors Corp2007-07-11AZATHIOPRINEORALTABLET658410602ANDA077621128846a7-18c6-4bc4-b3a0-9aeed0e8b986
3332610758ANDAAidarex Pharmaceuticals Llc2007-07-11AZATHIOPRINEORALTABLET683820003ANDA0776213ebf1c18-4ecd-486d-be4e-f1e765a9ad6d
4433530686ANDAAphena Pharma Solutions - Tennessee, Llc1996-02-16AZATHIOPRINEORALTABLET000544084ANDA074069d32704ed-df7f-4111-986d-229ae6f433af
5548685310ANDAPhysicians Total Care, Inc.2005-05-23AZATHIOPRINEORALTABLET683820003ANDA07762100e3b33f-2ee1-4cb4-8082-3d119754dbe3
6551544921ANDACardinal Health1996-02-16AZATHIOPRINEORALTABLET000548084ANDA07406982b29384-1243-4b98-82df-3708f5ce642a
7551544953ANDACardinal Health1996-02-16AZATHIOPRINEORALTABLET000544084ANDA07406949212741-389f-4112-94a9-d14ea2115825
8636295308ANDABryant Ranch Prepack2008-02-22AZATHIOPRINEORALTABLET680840229ANDA07762114c38a63-94ba-4d33-8989-7778d4f0b311
9680840229ANDAAmerican Health Packaging2008-02-22AZATHIOPRINEORALTABLET683820003ANDA077621040d010a-b1b2-4db7-905d-8aa7f1bab0cd

azathioprine 75 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1656490231AzasanANDASalix Pharmaceuticals, Inc.2003-04-01AZATHIOPRINEORALTABLETANDA0752529050af7a-19c6-4670-937a-9445605de995

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074069AZATHIOPRINEAMNEAL PHARMACEUTICALS LLC1996-02-16ANDA074069_001
2ANDA075252AZASANAAIPHARMA LLC1999-06-07ANDA075252_001, ANDA075252_002, ANDA075252_003, ANDA075252_004
3ANDA075568AZATHIOPRINEMYLAN PHARMACEUTICALS INC1999-12-13ANDA075568_001
4ANDA077621AZATHIOPRINEZYDUS PHARMACEUTICALS USA INC2007-03-15ANDA077621_001, ANDA077621_002, ANDA077621_003, ANDA077621_004
5NDA016324IMURANPROMETHEUS LABORATORIES INCNDA016324_001, NDA016324_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074069_001RXAZATHIOPRINE (50MG)ORALTABLETFalseAB1996-02-16AZATHIOPRINE
2ANDA075252_001RXAZATHIOPRINE (50MG)ORALTABLETFalseAB1999-06-07AZASAN
3ANDA075252_002RXAZATHIOPRINE (25MG)ORALTABLETFalseAB2003-02-03AZASAN
4ANDA075252_003RXAZATHIOPRINE (75MG)ORALTABLETFalseAB2003-02-03AZASAN
5ANDA075252_004RXAZATHIOPRINE (100MG)ORALTABLETFalseAB2003-02-03AZASAN
6ANDA075568_001RXAZATHIOPRINE (50MG)ORALTABLETFalseAB1999-12-13AZATHIOPRINE
7ANDA077621_001RXAZATHIOPRINE (50MG)ORALTABLETFalseAB2007-03-15AZATHIOPRINE
8ANDA077621_002RXAZATHIOPRINE (25MG)ORALTABLETFalseAB2008-09-05AZATHIOPRINE
9ANDA077621_003RXAZATHIOPRINE (75MG)ORALTABLETFalseAB2008-09-05AZATHIOPRINE
10ANDA077621_004RXAZATHIOPRINE (100MG)ORALTABLETFalseAB2008-09-05AZATHIOPRINE
11NDA016324_001RXAZATHIOPRINE (50MG)ORALTABLETTrueABIMURAN
12NDA016324_002discontinuedAZATHIOPRINE (25MG)ORALTABLETFalseIMURAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100e3b33f-2ee1-4cb4-8082-3d119754dbe3 (view SPL)Azathioprine Tablets, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-054548685310
2040d010a-b1b2-4db7-905d-8aa7f1bab0cd (view SPL)Azathioprine Tablets, USPprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-11-044680840229
30a83e716-b688-433f-ac27-ae95132810cf (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-307003781005
40b383e60-5353-4231-af66-b639a3b2f02c (view SPL)AZATHIOPRINE Tablets USP, 50 mgprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2010-05-034006157568
5128846a7-18c6-4bc4-b3a0-9aeed0e8b986 (view SPL)Azathioprine Tablets USPprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-12-241216950484
614c38a63-94ba-4d33-8989-7778d4f0b311 (view SPL)Azathioprine Tablets, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-06-051000636295308
7200ce996-da00-5be7-e054-00144ff8d46c (view SPL)prescriptionHuman PrescriptionGlenmark Generics Inc., Usaanalysis, manufacture, pack2015-09-181684620502
83ebf1c18-4ecd-486d-be4e-f1e765a9ad6d (view SPL)Azathioprine Tablets, USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-09-101332610758
949212741-389f-4112-94a9-d14ea2115825 (view SPL)AZATHIOPRINE Tablets USP, 50 mgprescriptionHuman PrescriptionCardinal HealthREPACK2010-12-101551544953
1082b29384-1243-4b98-82df-3708f5ce642a (view SPL)AZATHIOPRINE Tablets USP, 50 mgprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-082551544921
119050af7a-19c6-4670-937a-9445605de995 (view SPL)Azathioprine Tablets, 75mg and 100mgprescriptionHuman PrescriptionSalix Pharmaceuticals, Inc.analysis, manufacture, pack2015-11-0422656490231, 656490241
12aaa6c540-4c84-48a0-939c-cd423134fa2a (view SPL)IMURAN (azathioprine)50-mg Scored TabletsprescriptionHuman PrescriptionPrometheus Laboratories Inc.MANUFACTURE2014-01-0111654830590
13aeab212e-2f56-498d-a286-400ba360a7d2 (view SPL)AZATHIOPRINE Tablets USP, 50 mgprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-09-228000544084, 000548084
14b1b0fa3e-11c3-46d0-9537-6b372c2a1b56 (view SPL)Azathioprine Tablets, USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2014-02-135683820003
15c49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c (view SPL)AZATHIOPRINE Tablets USP, 50 mgprescriptionHuman PrescriptionAmneal Pharmaceuticals Of New York, LlcMANUFACTURE2015-03-252692381076
16d32704ed-df7f-4111-986d-229ae6f433af (view SPL)AZATHIOPRINE Tablets USP, 50 mgprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-06-242433530686
17d65bc662-2ae8-4ddb-acc8-f616e72e6140 (view SPL)Azathioprine Tablets, USPprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-11-294658410602
18e385894f-212b-4582-a63a-a0767fd97645 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2014-01-033510790620

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