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Active ingredient

Nifedipine

133 finished FDA listings contain Nifedipine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
NIFEDIPINE
Dosage forms
Capsule, Tablet, Extended Release, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
33
Strengths listed
10 mg/1 · 20 mg/1 · 30 mg/1 · 60 mg/1 · 90 mg/1
Brand names in FDA listings
Nifedipine Er, Procardia Xl

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7417

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 019684PFIZER1989-09-062
ANDA 072781ACELLA1993-07-301
ANDA 075289VALEANT PHARMS NORTH2000-09-273
ANDA 075269VALEANT PHARMS NORTH2000-12-049
ANDA 076070VALEANT PHARMS NORTH2002-08-163
ANDA 077127OSMOTICA PHARM US2005-11-2117
ANDA 202644HERITAGE PHARMA2013-04-258
ANDA 203126TWI PHARMS2014-04-0320
ANDA 202987NOVAST LABS2016-08-259
ANDA 210012ZYDUS PHARMS2017-12-196
ANDA 210184ZYDUS PHARMS2018-06-296
ANDA 210614NOVAST LABS2019-03-1224
ANDA 212016ELITE PHARM SOLUTION2020-11-181
ANDA 213361AUROBINDO PHARMA2021-07-198
ANDA 216067ALKEM LABS LTD2022-03-299
ANDA 216896ALEMBIC2022-11-186

Official labeling on DailyMed

Showing the 12 most recent of 88 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.