Nabumetone
Nabumetone Tablets USP
Approved
Approval ID
9df9212a-cf34-42b4-bd84-796b9e981eb0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2017
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-6046
Application NumberANDA078671
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumetone
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2015
FDA Product Classification
INGREDIENTS (10)
NABUMETONEActive
Quantity: 500 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 200Inactive
Code: R95B8J264J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT