Nabumetone
Nabumetone tablets
Approved
Approval ID
e66a5a08-7121-4987-bda1-7f3dbc5ed680
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2010
Manufacturers
FDA
Altura Pharmaceuticals, Inc.
DUNS: 006890545
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nabumetone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63874-607
Application NumberANDA076009
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumetone
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification
INGREDIENTS (11)
NABUMETONEActive
Quantity: 500 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Nabumetone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63874-687
Application NumberANDA076009
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumetone
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification
INGREDIENTS (12)
NABUMETONEActive
Quantity: 750 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT