Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aurobindo Pharma Limited
Aurobindo Pharma Limited
650381903
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen
Product Details
NDC Product Code
65862-520Application Number
ANDA200429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 6, 2024NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 250 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Naproxen
Product Details
NDC Product Code
65862-522Application Number
ANDA200429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 6, 2024NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 500 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Naproxen
Product Details
NDC Product Code
65862-521Application Number
ANDA200429Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 6, 2024NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 375 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT