Loperamide Hydrochloride
LOPERAMIDE HYDROCHLORIDE CAPSULES USP0311
Approved
Approval ID
5c2f4b11-6c45-4270-9b0b-ce73d5eae65f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-692
Application NumberANDA073192
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loperamide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2006
FDA Product Classification
INGREDIENTS (7)
Loperamide HydrochlorideActive
Quantity: 2 mg in 1 1
Code: 77TI35393C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
IRONInactive
Code: E1UOL152H7
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT