Loperamide Hydrochloride

Product NDC
71610-781
11-digit product format
716100781
Labeler code
71610
Product ID
71610-781_504a07f2-1cd9-4aa6-8f2f-dec486ac3ecd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA072741
Marketing category
ANDA
Marketing start
1991-09-18
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
77TI35393CLOPERAMIDE HYDROCHLORIDE34552-83-5LOPERAMIDE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-781-537161007815360 CAPSULE in 1 BOTTLE, PLASTIC (71610-781-53) 60 capsule2024-01-25NoNoHistorical
71610-781-607161007816090 CAPSULE in 1 BOTTLE, PLASTIC (71610-781-60) 90 capsule2024-01-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Loperamide Hydrochloride - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2024-02-01HUMAN PRESCRIPTION DRUG LABEL1