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FDA Approval

Captopril

CompanyBryant Ranch Prepack (DUNS: 171714327)

Effective Date

January 11, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Captopril(12.5 mg in 1 1)

Registrants (1)

Bryant Ranch Prepack

DUNS Number

171714327

Manufacturing Establishments (1)

Bryant Ranch Prepack

Labeler

Bryant Ranch Prepack

Registrant

Bryant Ranch Prepack

DUNS Number

171714327

Products (1)

Captopril

NDC Product Code

63629-8727

Application Number

ANDA074477

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2019

Ingredients

CaptoprilActive

Code: 9G64RSX1XDClass: ACTIBQuantity: 12.5 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

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