MedPath

Allopurinol

Approved
Approval ID

e1f42971-8169-4053-9857-585cef2ba7b0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 2

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 Code54868-0076
Application NumberNDA018877
Product Classification
M
Marketing Category
C73594
G
Generic Name
Allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2010
FDA Product Classification

INGREDIENTS (8)

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

Allopurinol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-0075
Application NumberNDA018832
Product Classification
M
Marketing Category
C73594
G
Generic Name
Allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2010
FDA Product Classification

INGREDIENTS (7)

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

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