Nabumetone
Nabumetone Tablets USP
Approved
Approval ID
3dda6795-861d-47cd-bf36-f5dd364fa7ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nabumetone
PRODUCT DETAILS
NDC Product Code52959-650
Application NumberANDA078671
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 20, 2011
Generic NameNabumetone
INGREDIENTS (9)
NABUMETONEActive
Quantity: 500 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Nabumetone
PRODUCT DETAILS
NDC Product Code52959-656
Application NumberANDA078671
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 20, 2011
Generic NameNabumetone
INGREDIENTS (10)
NABUMETONEActive
Quantity: 750 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT