Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
DIRECT RX
DIRECT RX
079254320
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NAPROXEN SODIUM
Product Details
NDC Product Code
61919-165Application Number
ANDA078432Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 21, 2020CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
NaproxenActive
Code: 9TN87S3A3CClass: ACTIBQuantity: 550 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MAGNESIUM SULFATE, UNSPECIFIEDInactive
Code: DE08037SABClass: IACT