Nifedipine

Product NDC
71610-689
11-digit product format
716100689
Labeler code
71610
Product ID
71610-689_57e2138d-9144-44c7-926e-73810d632cec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202987
Marketing category
ANDA
Marketing start
2016-08-25
Substance
NIFEDIPINE
Active strength
30 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
71610-689-307161006893030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-30) 2023-02-01NoNoHistorical
71610-689-537161006895360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-53) 2023-02-01NoNoHistorical
71610-689-607161006896090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-60) 2023-02-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nifedipine Extended-Release Tablets, USP 30mg, 60mg and 90mgAphena Pharma Solutions - Tennessee, LLC2023-02-01HUMAN PRESCRIPTION DRUG LABEL1