Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PSS World Medical Inc.
101822682
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
STAT Rx USA LLC
STAT Rx USA LLC
PSS World Medical Inc.
786036330
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
16590-423Application Number
ANDA073192Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 12, 2012MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LoperamideActive
Code: 77TI35393CClass: ACTIBQuantity: 2 mg in 1 1
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT