Nabumetone
Nabumetone Tablets, USP
Approved
Approval ID
bdbf4840-1880-4e29-b36c-5aaf4528e495
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2020
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nabumentone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0781
Application NumberANDA075280
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumentone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 27, 2019
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NABUMETONEActive
Quantity: 500 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Nabumentone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0754
Application NumberANDA075280
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumentone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 27, 2019
FDA Product Classification
INGREDIENTS (10)
NABUMETONEActive
Quantity: 750 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT