MedPath

Allopurinol

ALLOPURINOL tablets USP Rx Only

Approved
Approval ID

f396463f-b68b-578c-e053-2a95a90a938e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 7, 2023

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

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 Code68071-2926
Application NumberANDA211820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2023
FDA Product Classification

INGREDIENTS (6)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB

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