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FDA Approval

Hydrocodone Bitartrate and Acetaminophen

CompanyBryant Ranch Prepack (DUNS: 171714327)

Effective Date

November 27, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocodone(5 mg in 1 1)

Acetaminophen(325 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)

Hydrocodone Bitartrate and Acetaminophen

NDC Product Code

71335-9734

Application Number

ANDA202214

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 19, 2021

Ingredients

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 5 mg in 1 1

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

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