Amlodipine Besylate and Benazepril Hydrochloride

Product NDC

43063-571

11-digit product format

430630571

Labeler code

43063

Product ID

43063-571_a033b7c9-7af3-9c74-e053-2a95a90ae8c1

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amlodipine Besylate and Benazepril Hydrochloride

Dosage form

CAPSULE

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA078466

Marketing category

ANDA

Marketing start

2010-02-05

Marketing end

2020-03-31

Substance

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Active strength

5 mg/1; mg/1

Pharmacologic classes

Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record