NAPROXEN SODIUM
NAPROXEN SODIUM
Approved
Approval ID
16705fc3-5379-4557-94b6-fc5bfbbbc6d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2020
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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 Code61919-165
Application NumberANDA078432
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAPROXEN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2020
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 550 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM SULFATE, UNSPECIFIEDInactive
Code: DE08037SAB
Classification: IACT