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FDA Approval

Loperamide Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
REMEDYREPACK INC.
DUNS: 829572556
Effective Date
January 10, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Loperamide(2 mg in 1 1)

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
70518-3413
Application Number
ANDA215001
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 10, 2024
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: MB5IUD6JUAClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
Code: 77TI35393CClass: ACTIBQuantity: 2 mg in 1 1
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