FDA Product

Captopril

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

Basic Information

Product Name

Captopril

FDA Product Code

71335-2358

Regulatory Information

NDC Product Code

71335-2358

Application Number

ANDA212809

Marketing Category

C73584

Effective Date

November 23, 2021

Territorial Authority

USA

FDA Title

Captopril Tablets, USP Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

100

Company Information

ManufacturerBryant Ranch Prepack

DUNS Number

171714327

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

Quantity: 50 mg in 1 1

Code: 9G64RSX1XD

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

CAPTOPRIL

Code: 9G64RSX1XD

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