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.
Loperamide Hydrochloride
Product Details
NDC Product Code
68071-2257Application Number
ANDA073192Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 20, 2022DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LoperamideActive
Code: 77TI35393CClass: ACTIBQuantity: 2 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT