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
68071-4306Application Number
ANDA091625Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 16, 2021MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 400 mg in 1 1