MedPath

Allopurinol

AllopurinolTablets USP Rx only

Approved
Approval ID

632baede-6ade-450e-afa3-50a6cf1f9c91

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2020

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 2

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

Allopurinol

PRODUCT DETAILS

NDC Product Code50090-1867
Application NumberNDA018877
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 10, 2019
Generic NameAllopurinol

INGREDIENTS (8)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ALLOPURINOLActive
Quantity: 300 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT

Allopurinol

PRODUCT DETAILS

NDC Product Code50090-2544
Application NumberNDA018832
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 10, 2019
Generic NameAllopurinol

INGREDIENTS (7)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
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