Allopurinol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 191427277

Effective Date

September 13, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Allopurinol(300 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0904-6572

Application Number

ANDA075798

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 13, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Code: 63CZ7GJN5IClass: ACTIBQuantity: 300 mg in 1 1

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT