Loperamide Hydrochloride

Product NDC
68071-2700
11-digit product format
680712700
Labeler code
68071
Product ID
68071-2700_17dec409-07e2-7ecc-e063-6294a90ac555
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA215579
Marketing category
ANDA
Marketing start
2021-12-01
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
68071-2700-06807127000010 CAPSULE in 1 BOTTLE, PLASTIC (68071-2700-0) 10 capsule2022-05-18NoNoHistorical
68071-2700-16807127000112 CAPSULE in 1 BOTTLE, PLASTIC (68071-2700-1) 12 capsule2022-05-18NoNoHistorical
68071-2700-26807127000220 CAPSULE in 1 BOTTLE, PLASTIC (68071-2700-2) 20 capsule2022-05-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Loperamide Hydrochloride Capsules, USP Rx onlyNuCare Pharmaceuticals,Inc.2024-05-07HUMAN PRESCRIPTION DRUG LABEL3