Nifedipine

Product NDC
71610-055
11-digit product format
716100055
Labeler code
71610
Product ID
71610-055_9ac260ce-89b0-4218-9215-5e3ba9cba03f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076070
Marketing category
ANDA
Marketing start
2002-08-16
Substance
NIFEDIPINE
Active strength
90 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
I9ZF7L6G2LNIFEDIPINE21829-25-4NIFEDIPINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-055-607161000556090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-055-60) 2018-05-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nifedipine Extended-Release Tablets, USP 90 mgAphena Pharma Solutions - Tennessee, LLC2018-05-07HUMAN PRESCRIPTION DRUG LABEL1