MedPath
FDA Product

Amlodipine Besylate and Benazepril Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Amlodipine Besylate and Benazepril Hydrochloride

55111-340

Regulatory Information

55111-340

ANDA077183

C73584

December 23, 2022

USA

These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1995

HUMAN PRESCRIPTION DRUG LABEL

16

Company Information

650562841

Active Ingredients

Amlodipine Besylate

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

BENAZEPRIL HYDROCHLORIDE

Quantity: 20 mg in 1 1

Code: N1SN99T69T

Class Code: ACTIB

Inactive Ingredients

Crospovidone, Unspecified

Code: 2S7830E561

Class Code: IACT

Silicon Dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

HYDROGENATED CASTOR OIL

Code: ZF94AP8MEY

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

gelatin

Code: 2G86QN327L

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

AMLODIPINE

Code: 1J444QC288

BENAZEPRILAT

Code: JRM708L703

© Copyright 2025. All Rights Reserved by MedPath