RELAFEN DS
Nabumetone Tablets, USP
Approved
Approval ID
a9a0af85-6c43-4a2d-ba75-0be4ca64c931
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Carwin Pharmaceutical Associates, LLC
DUNS: 079217215
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 Code15370-170
Application NumberANDA203166
Product Classification
M
Marketing Category
C73584
G
Generic Name
NABUMETONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (8)
NABUMETONEActive
Quantity: 1000 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Hydroxypropyl Cellulose (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
Hypromellose 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT