Naproxen Sodium
Naproxen Sodium Tablets, USP 275 mg and 550 mg
Approved
Approval ID
0c01cb34-0d6b-4248-afde-82d4d934dabd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-090
Application NumberANDA078432
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2010
FDA Product Classification
INGREDIENTS (8)
NAPROXEN SODIUMActive
Quantity: 550 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT