Amlodipine Besylate

Product NDC

0378-5209

11-digit product format

003785209

Labeler code

0378

Product ID

0378-5209_2bca2c4d-60f5-438a-951c-c9ef69f98d48

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

amlodipine besylate

Dosage form

TABLET

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA076418

Marketing category

ANDA

Marketing start

2005-10-03

Marketing end

2020-08-31

Substance

AMLODIPINE BESYLATE

Active strength

5 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