Loperamide Hydrochloride

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

54868-2118

Application Number

ANDA072741

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 18, 2012

Ingredients

Code: 77TI35393CClass: ACTIBQuantity: 2 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT