FDA Product

Allopurinol

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

Basic Information

Product Name

Allopurinol

FDA Product Code

71335-9634

Regulatory Information

NDC Product Code

71335-9634

Application Number

ANDA204467

Marketing Category

C73584

Effective Date

May 26, 2023

Territorial Authority

USA

FDA Title

ALLOPURINOL TABLETS, USP Rx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

101

Company Information

ManufacturerBryant Ranch Prepack

DUNS Number

171714327

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Quantity: 300 mg in 1 1

Code: 63CZ7GJN5I

Class Code: ACTIB

Active Moieties

ALLOPURINOL

Code: 63CZ7GJN5I

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