Nifedipine

Product NDC

0378-0494

11-digit product format

003780494

Labeler code

0378

Product ID

0378-0494_b154bdb7-f761-491f-9a9c-14d23e9a1b52

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

nifedipine

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA090649

Marketing category

ANDA

Marketing start

2000-03-14

Marketing end

2019-11-30

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

0000-00-00

Current FDA listing

Historical FDA.report record