LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE CAPSULES USP0311Rx only
Approved
Approval ID
c97152f0-73ae-4463-8177-8f9250d84252
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code16590-423
Application NumberANDA073192
Product Classification
M
Marketing Category
C73584
G
Generic Name
LOPERAMIDE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2012
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LOPERAMIDE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 77TI35393C
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT