Anti-Diarrheal

Product NDC
68998-248
11-digit product format
689980248
Labeler code
68998
Product ID
68998-248_a9d20c87-e8b0-43dc-9a44-806668617978
Type
HUMAN OTC DRUG
Nonproprietary name
Marc Glassman
Dosage form
CAPSULE
Route
ORAL
Labeler
Marc Glassman, Inc.
Application
ANDA076497
Marketing category
ANDA
Marketing start
2005-05-03
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
68998-248-926899802489224 CAPSULE in 1 CARTON (68998-248-92) 24 capsule2005-05-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
248-Anti-DiarrhealMarc Glassman, Inc.2020-09-01HUMAN OTC DRUG LABEL5