Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NuCare Pharmaceuticals,Inc.
NuCare Pharmaceuticals,Inc.
010632300
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
NDC Product Code
68071-4965Application Number
ANDA078329Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 18, 2021STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT