LOPERAMIDE HYDROCHLORIDE

Product NDC
50090-7398
11-digit product format
500907398
Labeler code
50090
Product ID
50090-7398_fdda3cf0-8782-474c-95a7-5990383112f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA218122
Marketing category
ANDA
Marketing start
2023-09-05
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
50090-7398-05009073980015 CAPSULE in 1 BOTTLE (50090-7398-0) 15 capsule2024-10-23NoNoHistorical
50090-7398-35009073980312 CAPSULE in 1 BOTTLE (50090-7398-3) 12 capsule2024-10-23NoNoHistorical
50090-7398-45009073980430 CAPSULE in 1 BOTTLE (50090-7398-4) 30 capsule2024-10-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Loperamide Hydrochloride Capsules, USP Rx onlyA-S Medication Solutions2024-10-25Human Prescription Drug Label5