NABUMETONE
Nabumetone Tablets USP
Approved
Approval ID
11e2e5bf-c5bf-46db-920a-93711827aa5e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
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 Code42549-648
Application NumberANDA078671
Product Classification
M
Marketing Category
C73584
G
Generic Name
NABUMETONE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2012
FDA Product Classification
INGREDIENTS (10)
NABUMETONEActive
Quantity: 750 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT