Loperamide Hydrochloride

Product NDC
63629-8747
11-digit product format
636298747
Labeler code
63629
Product ID
63629-8747_c7bda4ce-21b5-419f-a6b1-e426edabeff1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA073192
Marketing category
ANDA
Marketing start
1993-05-01
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
63629-8747-163629874701100 CAPSULE in 1 BOTTLE (63629-8747-1) 100 capsule2021-08-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Loperamide Hydrochloride Capsules USP Rx onlyBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL105