Nifedipine Oral Capsule

Brand(s)
Procardia
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2013-08-05)
Oldest Current Product
1981-12-31
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\NIFEDIPINE
FDAOB
ORAL\CAPSULE\NIFEDIPINE
SPL Active
ORAL\CAPSULE, LIQUID FILLED\NIFEDIPINE
ORAL\CAPSULE\NIFEDIPINE
SPL Moiety
ORAL\CAPSULE, LIQUID FILLED\NIFEDIPINE
ORAL\CAPSULE\NIFEDIPINE

product(s) by strength(s)

nifedipine 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692600ProcardiaNDAPfizer Labs1981-12-31NIFEDIPINEORALCAPSULENDA018482e04aa152-b08d-47f7-b976-f8bee4c386db

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282497ANDAActavis Elizabeth Llc1991-01-01NIFEDIPINEORALCAPSULE, LIQUID FILLEDANDA072579ac0cd4d1-34c1-46b4-ad61-f10d7c0e06c9
2231550194ANDAHeritage Pharmaceuticals Inc.2010-12-07NIFEDIPINEORALCAPSULEANDA202644b8b8cfee-ea71-44c2-81af-675efecfdf15
3433860440ANDAGavis Pharmaceuticals, Llc2009-08-11NIFEDIPINEORALCAPSULEANDA0727810cc236dc-95fa-49cc-aeb8-6590de157585
4597621004NDA AUTHORIZED GENERICGreenstone Llc2013-03-25NIFEDIPINEORALCAPSULENDA0184829e5df4e1-be0d-4026-a7b0-3679b1effbde
5621128045ANDAIvc Industries, Inc. Dba Inverness Medical Nutritionals Group2009-08-01NIFEDIPINEORALCAPSULE, LIQUID FILLEDANDA072781a3daa0fc-7ec3-42c2-91b2-8418331dd0fc

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900319ANDAStat Rx Usa Llc1989-04-28NIFEDIPINEORALCAPSULE, LIQUID FILLED002282497ANDA0725790d592c37-b38c-4fb6-a1d3-96531384ae8d
2502680600ANDAAvpak2015-07-29NIFEDIPINEORALCAPSULE, LIQUID FILLED002282497ANDA072579cb526578-9118-e9b0-d1dd-4324e62c7d79
3521250126ProcardiaNDARemedyrepack Inc.2013-02-25NIFEDIPINEORALCAPSULE000692600NDA0184827dec6ce7-cd5f-43be-b050-b8103d35f0bc
4545693121ANDAA-S Medication Solutions Llc1991-01-01NIFEDIPINEORALCAPSULE, LIQUID FILLED002282497ANDA072579b4ea74cc-ce54-448c-8982-b900e5a6ac8a
5548681326ANDAPhysicians Total Care, Inc.2009-01-29NIFEDIPINEORALCAPSULE, LIQUID FILLED002282497ANDA0725795733e038-7cb5-434b-aa8e-abb25e6252c9
6551544994ANDACardinal Health2013-06-05NIFEDIPINEORALCAPSULE, LIQUID FILLED680840022ANDA07257921ee6e6e-7660-449f-81de-2ed341ec7583
7551545979ANDACardinal Health1991-01-08NIFEDIPINEORALCAPSULE, LIQUID FILLED002282497ANDA0725791ee3c427-81f4-4bdd-a17b-138553c57369
8552890907ANDAPd-Rx Pharmaceuticals, Inc.2009-08-11NIFEDIPINEORALCAPSULE433860440ANDA07278140737470-a8ab-4497-bf0c-f16fdba343be
9604290163ANDAGolden State Medical Supply, Inc.2009-08-11NIFEDIPINEORALCAPSULE433860440ANDA0727812d934d80-6d28-415d-8963-bf8d1e4b038c
10636291558ANDABryant Ranch Prepack2009-08-11NIFEDIPINEORALCAPSULE433860440ANDA0727811937ff14-34a2-40b4-3261-7e3f484409fe
11680840022ANDAAmerican Health Packaging2013-06-05NIFEDIPINEORALCAPSULE, LIQUID FILLED002282497ANDA0725796e4f8ed9-ad15-411d-a081-c6a2874b7298
12681512870ANDACarilion Materials Management2009-08-11NIFEDIPINEORALCAPSULE433860440ANDA072781ce3366e2-ede3-4321-bd1c-8aacc869fe46

nifedipine 20 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282530ANDAActavis Elizabeth Llc1990-09-20NIFEDIPINEORALCAPSULE, LIQUID FILLEDANDA072556ac0cd4d1-34c1-46b4-ad61-f10d7c0e06c9

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680601ANDAAvpak2015-07-29NIFEDIPINEORALCAPSULE, LIQUID FILLED002282530ANDA072556cb526578-9118-e9b0-d1dd-4324e62c7d79
2548681521ANDAPhysicians Total Care, Inc.2001-01-152011-06-30NIFEDIPINEORALCAPSULE, LIQUID FILLED002282530ANDA0725795733e038-7cb5-434b-aa8e-abb25e6252c9
3551545980ANDACardinal Health1990-09-20NIFEDIPINEORALCAPSULE, LIQUID FILLED002282530ANDA0725561ee3c427-81f4-4bdd-a17b-138553c57369
4680840923ANDAAmerican Health Packaging2015-03-31NIFEDIPINEORALCAPSULE, LIQUID FILLED002282530ANDA072556eeef0cdb-7b0b-49e0-a1ed-78311e9f531b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA072409NIFEDIPINETrueCHASE LABORATORIES INC1990-07-04ANDA072409_001
2ANDA072556NIFEDIPINEACTAVIS ELIZABETH LLC1990-09-20ANDA072556_001
3ANDA072579NIFEDIPINEACTAVIS ELIZABETH LLC1991-01-08ANDA072579_001
4ANDA072651NIFEDIPINETrueTEVA PHARMACEUTICALS USA INC1992-02-19ANDA072651_001
5ANDA072781NIFEDIPINEINTERGEL PHARMACEUTICAL INC1993-07-30ANDA072781_001
6ANDA073250NIFEDIPINETrueCATALENT PHARMA SOLUTIONS LLC1991-10-08ANDA073250_001
7ANDA073421NIFEDIPINETrueCHASE LABORATORIES INC1991-06-19ANDA073421_001
8ANDA074045NIFEDIPINETrueCATALENT PHARMA SOLUTIONS LLC1992-04-30ANDA074045_001
9ANDA202644NIFEDIPINEHERITAGE PHARMA LABS INC2013-04-25ANDA202644_001, ANDA202644_002
10NDA018482PROCARDIAPFIZER INCNDA018482_001, NDA018482_002
11NDA019478ADALATTrueBAYER PHARMACEUTICALS CORP1985-11-27NDA019478_001, NDA019478_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA072409_001discontinuedNIFEDIPINE (10MG)ORALCAPSULEFalse1990-07-04NIFEDIPINE
2ANDA072556_001RXNIFEDIPINE (20MG)ORALCAPSULEFalseAB1990-09-20NIFEDIPINE
3ANDA072579_001RXNIFEDIPINE (10MG)ORALCAPSULEFalseAB1991-01-08NIFEDIPINE
4ANDA072651_001discontinuedNIFEDIPINE (10MG)ORALCAPSULEFalse1992-02-19NIFEDIPINE
5ANDA072781_001RXNIFEDIPINE (10MG)ORALCAPSULEFalseAB1993-07-30NIFEDIPINE
6ANDA073250_001discontinuedNIFEDIPINE (10MG)ORALCAPSULEFalse1991-10-08NIFEDIPINE
7ANDA073421_001discontinuedNIFEDIPINE (20MG)ORALCAPSULEFalse1991-06-19NIFEDIPINE
8ANDA074045_001discontinuedNIFEDIPINE (20MG)ORALCAPSULEFalse1992-04-30NIFEDIPINE
9ANDA202644_001RXNIFEDIPINE (10MG)ORALCAPSULEFalseAB2013-04-25NIFEDIPINE
10ANDA202644_002RXNIFEDIPINE (20MG)ORALCAPSULEFalseAB2013-04-25NIFEDIPINE
11NDA018482_001RXNIFEDIPINE (10MG)ORALCAPSULETrueABPROCARDIA
12NDA018482_002discontinuedNIFEDIPINE (20MG)ORALCAPSULEFalse1986-07-24PROCARDIA
13NDA019478_001discontinuedNIFEDIPINE (10MG)ORALCAPSULEFalse1985-11-27ADALAT
14NDA019478_002discontinuedNIFEDIPINE (20MG)ORALCAPSULEFalse1986-09-17ADALAT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10cc236dc-95fa-49cc-aeb8-6590de157585 (view SPL)Nifedipine CapsulesprescriptionHuman PrescriptionGavis Pharmaceuticals, Llcanalysis, manufacture, repack2009-08-031433860440
20d592c37-b38c-4fb6-a1d3-96531384ae8d (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-06-091165900319
31937ff14-34a2-40b4-3261-7e3f484409fe (view SPL)Nifedipine CapsulesprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-183636291558
41ee3c427-81f4-4bdd-a17b-138553c57369 (view SPL)NIFEDIPINE CAPSULES, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-07-226551545979, 551545980
521ee6e6e-7660-449f-81de-2ed341ec7583 (view SPL)NIFEDIPINE CAPSULES, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-01-141551544994
62d934d80-6d28-415d-8963-bf8d1e4b038c (view SPL)Nifedipine Capsules, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290163
740737470-a8ab-4497-bf0c-f16fdba343be (view SPL)Nifedipine CapsulesprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-08-032552890907
85733e038-7cb5-434b-aa8e-abb25e6252c9 (view SPL)NIFEDIPINE CAPSULES, USP 40-8986 Revised November 2008 Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-06-263548681326, 548681521
96e4f8ed9-ad15-411d-a081-c6a2874b7298 (view SPL)NIFEDIPINE CAPSULES, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-214680840022
107dec6ce7-cd5f-43be-b050-b8103d35f0bc (view SPL)PROCARDIA (nifedipine) CAPSULES For Oral UseprescriptionHuman PrescriptionRemedyrepack Inc.2013-02-252521250126
119e5df4e1-be0d-4026-a7b0-3679b1effbde (view SPL)NIFEDIPINE CAPSULES For Oral UseprescriptionHuman PrescriptionGreenstone LlcAPI MANUFACTURE, MANUFACTURE, PACK, REPACK2015-02-114597621004
12a3daa0fc-7ec3-42c2-91b2-8418331dd0fc (view SPL)prescriptionHuman PrescriptionIvc Industries, Inc. Dba Inverness Medical Nutritionals Group2009-10-212621128045
13ac0cd4d1-34c1-46b4-ad61-f10d7c0e06c9 (view SPL)NIFEDIPINE CAPSULES, USPprescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-06-3010002282497, 002282530
14b4ea74cc-ce54-448c-8982-b900e5a6ac8a (view SPL)NIFEDIPINE CAPSULES, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-10-261545693121
15b8b8cfee-ea71-44c2-81af-675efecfdf15 (view SPL)Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-06-2910231550194
16cb526578-9118-e9b0-d1dd-4324e62c7d79 (view SPL)NIFEDIPINE CAPSULES, USPprescriptionHuman PrescriptionAvpak2015-07-292502680600, 502680601
17ce3366e2-ede3-4321-bd1c-8aacc869fe46 (view SPL)Nifedipine CapsulesprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2009-08-032681512870
18e04aa152-b08d-47f7-b976-f8bee4c386db (view SPL)PROCARDIA (nifedipine) CAPSULES For Oral UseprescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, MANUFACTURE, PACK, REPACK2013-08-056000692600
19eeef0cdb-7b0b-49e0-a1ed-78311e9f531b (view SPL)NIFEDIPINE CAPSULES, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-211680840923

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