Desipramine Oral Tablet

Brand(s)
Norpramin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2014-06-04)
Oldest Current Product
1964-11-20
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\DESIPRAMINE
FDAOB
ORAL\TABLET\DESIPRAMINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\DESIPRAMINE HYDROCHLORIDE
ORAL\TABLET, SUGAR COATED\DESIPRAMINE HYDROCHLORIDE
ORAL\TABLET\DESIPRAMINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\DESIPRAMINE
ORAL\TABLET, SUGAR COATED\DESIPRAMINE
ORAL\TABLET\DESIPRAMINE

product(s) by strength(s)

desipramine hydrochloride 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680007NorpraminNDASanofi-Aventis U.S. Llc1964-11-20DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA0143993e593725-3fc9-458e-907d-19d51d5a7f9c

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1007811971ANDASandoz Inc1988-05-242016-12-31DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0720997ec5f73f-32b6-48c3-b16e-891d06edf6eb
2007815218ANDASandoz Inc2015-06-24DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0720997ec5f73f-32b6-48c3-b16e-891d06edf6eb
3009551030NDA AUTHORIZED GENERICWinthrop U.S.2014-04-01DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA01439991304d6c-8e23-4c00-85cd-5b8e2a784c38
4459630341ANDAActavis Inc.2006-05-09DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA074430ba02a95d-d82e-4a13-90b4-a219abc0249a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790120ANDAKaiser Foundations Hospitals2012-05-31DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED459630341ANDA0744307500ac1b-a1ca-46ed-8f4e-5998310c676e
2165900830ANDAStat Rx Usa Llc1988-05-24DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED007811971ANDA072099711d8455-9ce1-45b4-875d-007b2e0b27ec
3216950845ANDARebel Distributors Corp1996-02-09DESIPRAMINE HYDROCHLORIDEORALTABLET521520341ANDA0744303433c754-cc2e-4e72-bd82-16ed4af3144d
4493490172ANDARemedyrepack Inc.2011-04-18DESIPRAMINE HYDROCHLORIDEORALTABLET007811971ANDA0720996d835181-0454-4edb-b523-940afcd4674f
5681512482ANDACarilion Materials Management1988-05-24DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED007811971ANDA072099b5e9fa99-e2dd-4271-8bd4-ea865b6ddb48

desipramine hydrochloride 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680020NorpraminNDASanofi-Aventis U.S. Llc1964-11-20DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA0143993e593725-3fc9-458e-907d-19d51d5a7f9c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007811975ANDASandoz Inc1988-06-20DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0721037ec5f73f-32b6-48c3-b16e-891d06edf6eb
2009551034NDA AUTHORIZED GENERICWinthrop U.S.2014-04-01DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA01439991304d6c-8e23-4c00-85cd-5b8e2a784c38
3459630345ANDAActavis Inc.2006-07-19DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA071766ba02a95d-d82e-4a13-90b4-a219abc0249a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900586ANDAStat Rx Usa Llc1988-06-20DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED007811975ANDA072103711d8455-9ce1-45b4-875d-007b2e0b27ec
2636293990ANDABryant Ranch Prepack1988-06-20DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED007811975ANDA0721037017228d-3cd8-470b-b642-3634ddda500c

desipramine hydrochloride 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680021NorpraminNDASanofi-Aventis U.S. Llc1964-11-20DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA0143993e593725-3fc9-458e-907d-19d51d5a7f9c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007811976ANDASandoz Inc1988-06-20DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0721047ec5f73f-32b6-48c3-b16e-891d06edf6eb
2009551035NDA AUTHORIZED GENERICWinthrop U.S.2014-04-01DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA01439991304d6c-8e23-4c00-85cd-5b8e2a784c38
3459630346ANDAActavis Inc.2006-05-09DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA074430ba02a95d-d82e-4a13-90b4-a219abc0249a

desipramine hydrochloride 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680011NorpraminNDASanofi-Aventis U.S. Llc1964-11-20DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA0143993e593725-3fc9-458e-907d-19d51d5a7f9c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007811972ANDASandoz Inc1988-05-24DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0721007ec5f73f-32b6-48c3-b16e-891d06edf6eb
2009551031NDA AUTHORIZED GENERICWinthrop U.S.2014-04-01DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA01439991304d6c-8e23-4c00-85cd-5b8e2a784c38
3459630342ANDAActavis Inc.2006-05-01DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA071601ba02a95d-d82e-4a13-90b4-a219abc0249a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950428ANDARebel Distributors Corp1988-05-24DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED007811972ANDA072100f3127fff-2943-424d-8b8b-80aa320a2d07
2493490582ANDARemedyrepack Inc.2011-10-12DESIPRAMINE HYDROCHLORIDEORALTABLET521520342ANDA072100debf74d1-3250-4858-8a9d-638262f3a7d5
3636293645ANDABryant Ranch Prepack1988-05-24DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED007811972ANDA072100be70fddf-644a-44ad-bfdf-0914dd12b1af
4680840972ANDAAmerican Health Packaging2015-09-01DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED007811972ANDA072100e2d7141a-f90d-491d-872f-50f6a90d723c
5687889826ANDAPreferred Pharmaceuticals, Inc.2012-04-05DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED521520342ANDA071601c7cdd04c-6c34-4780-8b21-a6f9fc74cf46

desipramine hydrochloride 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680015NorpraminNDASanofi-Aventis U.S. Llc1964-11-20DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA0143993e593725-3fc9-458e-907d-19d51d5a7f9c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007811973ANDASandoz Inc1988-05-24DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0721017ec5f73f-32b6-48c3-b16e-891d06edf6eb
2009551032NDA AUTHORIZED GENERICWinthrop U.S.2014-04-01DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA01439991304d6c-8e23-4c00-85cd-5b8e2a784c38
3459630343ANDAActavis Inc.2006-06-04DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA071588ba02a95d-d82e-4a13-90b4-a219abc0249a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490136ANDARemedyrepack Inc.2011-04-04DESIPRAMINE HYDROCHLORIDEORALTABLET52152034302ANDA071588d6fc590a-7ff9-488c-9898-eec926303b76
2493490198ANDARemedyrepack Inc.2011-04-21DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED007811973ANDA072101b8fc7086-c034-41c2-aa24-ca30c45753f5
3493490515ANDARemedyrepack Inc.2011-09-19DESIPRAMINE HYDROCHLORIDEORALTABLET521520343ANDA071588a767e888-f825-4429-b3a4-05580ea6d157
4636295027ANDABryant Ranch Prepack2006-06-04DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATED459630343ANDA07158889b0438b-9701-4c1b-9e8a-f0a32c3af916

desipramine hydrochloride 75 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680019NorpraminNDASanofi-Aventis U.S. Llc1964-11-20DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA0143993e593725-3fc9-458e-907d-19d51d5a7f9c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007811974ANDASandoz Inc1988-06-20DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0721027ec5f73f-32b6-48c3-b16e-891d06edf6eb
2009551033NDA AUTHORIZED GENERICWinthrop U.S.2014-04-01DESIPRAMINE HYDROCHLORIDEORALTABLET, SUGAR COATEDNDA01439991304d6c-8e23-4c00-85cd-5b8e2a784c38
3459630344ANDAActavis Inc.2006-05-08DESIPRAMINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA071602ba02a95d-d82e-4a13-90b4-a219abc0249a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071588DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWA LLC1987-06-05ANDA071588_001
2ANDA071601DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWA LLC1987-06-05ANDA071601_001
3ANDA071602DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWA LLC1987-10-05ANDA071602_001
4ANDA071766DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWA LLC1987-10-05ANDA071766_001
5ANDA071803DESIPRAMINE HYDROCHLORIDEANI PHARMACEUTICALS INC1987-12-08ANDA071803_001, ANDA071803_002, ANDA071803_003, ANDA071803_004, ANDA071803_005
6ANDA071864DESIPRAMINE HYDROCHLORIDETrueUSL PHARMA INC1987-09-09ANDA071864_001
7ANDA071865DESIPRAMINE HYDROCHLORIDETrueUSL PHARMA INC1987-09-09ANDA071865_001
8ANDA071866DESIPRAMINE HYDROCHLORIDETrueUSL PHARMA INC1987-09-09ANDA071866_001
9ANDA071867DESIPRAMINE HYDROCHLORIDETrueUSL PHARMA INC1987-09-09ANDA071867_001
10ANDA072099DESIPRAMINE HYDROCHLORIDESANDOZ INC1988-05-24ANDA072099_001
11ANDA072100DESIPRAMINE HYDROCHLORIDESANDOZ INC1988-05-24ANDA072100_001
12ANDA072101DESIPRAMINE HYDROCHLORIDESANDOZ INC1988-05-24ANDA072101_001
13ANDA072102DESIPRAMINE HYDROCHLORIDESANDOZ INC1988-06-20ANDA072102_001
14ANDA072103DESIPRAMINE HYDROCHLORIDESANDOZ INC1988-06-20ANDA072103_001
15ANDA072104DESIPRAMINE HYDROCHLORIDESANDOZ INC1988-06-20ANDA072104_001
16ANDA074430DESIPRAMINE HYDROCHLORIDEACTAVIS TOTOWA LLC1996-02-09ANDA074430_001, ANDA074430_002
17NDA014399NORPRAMINSANOFI AVENTIS US LLCNDA014399_001, NDA014399_003, NDA014399_004, NDA014399_005, NDA014399_006, NDA014399_007

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA071588_001RXDESIPRAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB1987-06-05DESIPRAMINE HYDROCHLORIDE
2ANDA071601_001RXDESIPRAMINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB1987-06-05DESIPRAMINE HYDROCHLORIDE
3ANDA071602_001RXDESIPRAMINE HYDROCHLORIDE (75MG)ORALTABLETFalseAB1987-10-05DESIPRAMINE HYDROCHLORIDE
4ANDA071766_001RXDESIPRAMINE HYDROCHLORIDE (100MG)ORALTABLETFalseAB1987-10-05DESIPRAMINE HYDROCHLORIDE
5ANDA071803_001discontinuedDESIPRAMINE HYDROCHLORIDE (100MG)ORALTABLETFalse1997-05-29DESIPRAMINE HYDROCHLORIDE
6ANDA071803_002RXDESIPRAMINE HYDROCHLORIDE (25MG)ORALTABLETFalse1987-12-08DESIPRAMINE HYDROCHLORIDE
7ANDA071803_003RXDESIPRAMINE HYDROCHLORIDE (50MG)ORALTABLETFalse1987-12-08DESIPRAMINE HYDROCHLORIDE
8ANDA071803_004RXDESIPRAMINE HYDROCHLORIDE (75MG)ORALTABLETFalse1987-12-08DESIPRAMINE HYDROCHLORIDE
9ANDA071803_005RXDESIPRAMINE HYDROCHLORIDE (150MG)ORALTABLETFalse1997-05-29DESIPRAMINE HYDROCHLORIDE
10ANDA071864_001discontinuedDESIPRAMINE HYDROCHLORIDE (25MG)ORALTABLETFalse1987-09-09DESIPRAMINE HYDROCHLORIDE
11ANDA071865_001discontinuedDESIPRAMINE HYDROCHLORIDE (50MG)ORALTABLETFalse1987-09-09DESIPRAMINE HYDROCHLORIDE
12ANDA071866_001discontinuedDESIPRAMINE HYDROCHLORIDE (75MG)ORALTABLETFalse1987-09-09DESIPRAMINE HYDROCHLORIDE
13ANDA071867_001discontinuedDESIPRAMINE HYDROCHLORIDE (100MG)ORALTABLETFalse1987-09-09DESIPRAMINE HYDROCHLORIDE
14ANDA072099_001RXDESIPRAMINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB1988-05-24DESIPRAMINE HYDROCHLORIDE
15ANDA072100_001RXDESIPRAMINE HYDROCHLORIDE (25MG)ORALTABLETFalseAB1988-05-24DESIPRAMINE HYDROCHLORIDE
16ANDA072101_001RXDESIPRAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseAB1988-05-24DESIPRAMINE HYDROCHLORIDE
17ANDA072102_001RXDESIPRAMINE HYDROCHLORIDE (75MG)ORALTABLETFalseAB1988-06-20DESIPRAMINE HYDROCHLORIDE
18ANDA072103_001RXDESIPRAMINE HYDROCHLORIDE (100MG)ORALTABLETFalseAB1988-06-20DESIPRAMINE HYDROCHLORIDE
19ANDA072104_001RXDESIPRAMINE HYDROCHLORIDE (150MG)ORALTABLETFalseAB1988-06-20DESIPRAMINE HYDROCHLORIDE
20ANDA074430_001RXDESIPRAMINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB1996-02-09DESIPRAMINE HYDROCHLORIDE
21ANDA074430_002RXDESIPRAMINE HYDROCHLORIDE (150MG)ORALTABLETFalseAB1996-02-09DESIPRAMINE HYDROCHLORIDE
22NDA014399_001RXDESIPRAMINE HYDROCHLORIDE (25MG)ORALTABLETFalseABNORPRAMIN
23NDA014399_003RXDESIPRAMINE HYDROCHLORIDE (50MG)ORALTABLETFalseABNORPRAMIN
24NDA014399_004RXDESIPRAMINE HYDROCHLORIDE (75MG)ORALTABLETFalseABNORPRAMIN
25NDA014399_005RXDESIPRAMINE HYDROCHLORIDE (100MG)ORALTABLETTrueABNORPRAMIN
26NDA014399_006RXDESIPRAMINE HYDROCHLORIDE (150MG)ORALTABLETFalseABNORPRAMIN
27NDA014399_007RXDESIPRAMINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB1982-02-11NORPRAMIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13433c754-cc2e-4e72-bd82-16ed4af3144d (view SPL)DESIPRAMINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-04-131216950845
23e593725-3fc9-458e-907d-19d51d5a7f9c (view SPL)NORPRAMIN (desipramine hydrochloride tablets USP)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-06-0410000680007, 000680011, 000680015, 000680019, 000680020, 000680021
36d835181-0454-4edb-b523-940afcd4674f (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-04-186493490172
47017228d-3cd8-470b-b642-3634ddda500c (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-171001636293990
5711d8455-9ce1-45b4-875d-007b2e0b27ec (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-07-091165900586, 165900830
67500ac1b-a1ca-46ed-8f4e-5998310c676e (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2012-05-311001790120
77ec5f73f-32b6-48c3-b16e-891d06edf6eb (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionSandoz Inc2015-06-2418007811971, 007811972, 007811973, 007811974, 007811975, 007811976, 007815218
889b0438b-9701-4c1b-9e8a-f0a32c3af916 (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-08-201000636295027
991304d6c-8e23-4c00-85cd-5b8e2a784c38 (view SPL)Desipramine Hydrochloride Tablets USPprescriptionHuman PrescriptionWinthrop U.S.ANALYSIS, LABEL, MANUFACTURE, PACK2014-08-045009551030, 009551031, 009551032, 009551033, 009551034, 009551035
10a767e888-f825-4429-b3a4-05580ea6d157 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-191493490515
11b5e9fa99-e2dd-4271-8bd4-ea865b6ddb48 (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-02-152681512482
12b8fc7086-c034-41c2-aa24-ca30c45753f5 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-04-211493490198
13ba02a95d-d82e-4a13-90b4-a219abc0249a (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionActavis Inc.MANUFACTURE, PACK2014-07-3012459630341, 459630342, 459630343, 459630344, 459630345, 459630346
14be70fddf-644a-44ad-bfdf-0914dd12b1af (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636293645
15c7cdd04c-6c34-4780-8b21-a6f9fc74cf46 (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-11-142687889826
16d6fc590a-7ff9-488c-9898-eec926303b76 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-04-041493490136
17debf74d1-3250-4858-8a9d-638262f3a7d5 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-10-121493490582
18e2d7141a-f90d-491d-872f-50f6a90d723c (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-131680840972
19f3127fff-2943-424d-8b8b-80aa320a2d07 (view SPL)Desipramine Hydrochloride Tablets, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-171216950428

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