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FDA Approval

Oxycodone Hydrochloride

CompanyBryant Ranch Prepack (DUNS: 171714327)

Effective Date

March 30, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oxycodone(15 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)

Oxycodone Hydrochloride

NDC Product Code

72162-1336

Application Number

ANDA091490

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 16, 2021

Ingredients

OxycodoneActive

Code: C1ENJ2TE6CClass: ACTIBQuantity: 15 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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