Loperamide Hydrochloride

Product NDC
70934-546
11-digit product format
709340546
Labeler code
70934
Product ID
70934-546_ac8c6156-56d8-13a8-e053-2a95a90aeadf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA073192
Marketing category
ANDA
Marketing start
2020-02-06
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-546-157093405461515 CAPSULE in 1 BOTTLE, PLASTIC (70934-546-15) 15 capsule2020-02-060000-00-00NoNoCurrent