Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Quality Care Products, LLC
Quality Care Products, LLC
831276758
Products1
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
55700-888Application Number
ANDA212517Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 18, 2021FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
NaproxenActive
Code: 57Y76R9ATQClass: ACTIBQuantity: 500 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT