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Allopurinol

PRODUCT INFORMATION Allopurinol Tablets USP 100 mg and 300 mg Tablets

Approved
Approval ID

c6c33885-7d24-4029-bba1-66dbfa45c8a0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 5, 2024

Manufacturers
FDA

REMEDYREPACK INC.

DUNS: 829572556

Products 1

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

allopurinol

PRODUCT DETAILS

NDC Product Code70518-0451
Application NumberANDA203154
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 5, 2024
Generic Nameallopurinol

INGREDIENTS (6)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
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Allopurinol - FDA Approval | MedPath