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
68071-3849Application Number
ANDA202413Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 14, 2025SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 600 mg in 1 1