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.
IBU
Product Details
NDC Product Code
68071-3125Application Number
ANDA075682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 14, 2022CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 600 mg in 1 1