Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products2
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
54868-3043Application Number
ANDA078314Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 11, 2012NaproxenActive
Code: 9TN87S3A3CClass: ACTIBQuantity: 550 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Naproxen Sodium
Product Details
NDC Product Code
54868-3359Application Number
ANDA078314Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 11, 2012CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
NaproxenActive
Code: 9TN87S3A3CClass: ACTIBQuantity: 275 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT