Loperamide Hydrochloride
Approved
Approval ID
a66d2f97-8d22-482d-b18b-f58f1d882f42
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
loperamide hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2118
Application NumberANDA072741
Product Classification
M
Marketing Category
C73584
G
Generic Name
loperamide hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2012
FDA Product Classification
INGREDIENTS (9)
LOPERAMIDE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 77TI35393C
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT