Amlodipine Besylate

Product NDC

67544-979

11-digit product format

675440979

Labeler code

67544

Product ID

67544-979_a2dfcc60-93ad-4523-aa81-fd2e2ed3a954

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

amlodipine besylate

Dosage form

TABLET

Route

ORAL

Labeler

Aphena Pharma Solutions - Tennessee, LLC

Application

ANDA076418

Marketing category

ANDA

Marketing start

2005-10-03

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record