RELAFEN
RELAFEN (NABUMETONE TABLETS USP)
Approved
Approval ID
738cb807-2d77-4d65-a0f5-2afb9bd65725
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2021
Manufacturers
FDA
BLUCREST PHARMACEUTICALS LLC
DUNS: 117424533
Products 2
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 Code73684-100
Application NumberANDA203166
Product Classification
M
Marketing Category
C73584
G
Generic Name
NABUMETONE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2021
FDA Product Classification
INGREDIENTS (3)
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
NABUMETONEActive
Quantity: 500 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
Hydroxypropyl Cellulose (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
NABUMETONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73684-101
Application NumberANDA203166
Product Classification
M
Marketing Category
C73584
G
Generic Name
NABUMETONE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2021
FDA Product Classification
INGREDIENTS (3)
NABUMETONEActive
Quantity: 750 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
Hydroxypropyl Cellulose (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT