Nabumetone 500 mg
NABUMETONE TABLETS USP Rx Only
Approved
Approval ID
0d5a5b1c-e3a7-4f90-a457-0fb6f44dbc8d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2019
Manufacturers
FDA
Nexgen Pharma, Inc.
DUNS: 048488621
Products 3
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 Code0722-7076
Application NumberANDA203166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumetone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2019
FDA Product Classification
INGREDIENTS (3)
NABUMETONEActive
Quantity: 500 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Quantity: 30 mg in 1 1
Code: FZ989GH94E
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Quantity: 2.85 mg in 1 1
Code: UKE75GEA7F
Classification: IACT
Nabumetone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0722-7077
Application NumberANDA203166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumetone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2019
FDA Product Classification
INGREDIENTS (3)
NABUMETONEActive
Quantity: 750 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Quantity: 4.275 mg in 1 1
Code: UKE75GEA7F
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Quantity: 45 mg in 1 1
Code: FZ989GH94E
Classification: IACT
Nabumetone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0722-7078
Application NumberANDA203166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumetone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2019
FDA Product Classification
INGREDIENTS (3)
NABUMETONEActive
Quantity: 1000 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Quantity: 60 mg in 1 1
Code: FZ989GH94E
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Quantity: 5.7 mg in 1 1
Code: UKE75GEA7F
Classification: IACT