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Allopurinol

Allopurinol Tablets USP

Approved
Approval ID

f91c2183-e41d-45bc-87aa-edfca5eebac5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 28, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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

allopurinol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63629-2111
Application NumberANDA075798
Product Classification
M
Marketing Category
C73584
G
Generic Name
allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 10, 2019
FDA Product Classification

INGREDIENTS (6)

ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 7/10/2019

DESCRIPTION

Allopurinol, USP has the following structural formula:

This is an image of the structural formula of allopurinol.

Allopurinol, USP is known chemically as 1, 5-dihydro-4 H-pyrazolo [3, 4- d] pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allopurinol and the inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Each scored orange tablet contains 300 mg allopurinol and the inactive ingredients colloidal silicon dioxide, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Soluble in solutions of potassium and sodium hydroxides, very slightly soluble in water and in alcohol; practically insoluble in chloroform and in ether.

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Allopurinol - FDA Drug Approval Details