Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals, LLC
Amneal Pharmaceuticals of New York LLC
969951594
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
53746-190Application Number
ANDA075927Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 20, 2021NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 500 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Naproxen
Product Details
NDC Product Code
53746-188Application Number
ANDA075927Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 20, 2021NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 250 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Naproxen
Product Details
NDC Product Code
53746-189Application Number
ANDA075927Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 20, 2021NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 375 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
Warnings and Precautions (5.10, 5.11) 04/2021