core values anti diarrheal

Product NDC
63940-119
11-digit product format
639400119
Labeler code
63940
Product ID
63940-119_fff00fd0-0dae-4abd-8581-cabbd6b28fe8
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Harmon Stores Inc.
Application
ANDA075232
Marketing category
ANDA
Marketing start
2017-07-28
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63940-119-532025-02-13C16284748780-12cef2736-7c10-d83d-e063-dadaa90ab31f5ad6eec5-ee66-4936-9859-8ba45ecae587
63940-119-532025-01-30C16284748780-12cef2736-7c10-d83d-e063-dadaa90ab31f5ad6eec5-ee66-4936-9859-8ba45ecae587

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63940-119-536394001195312 BLISTER PACK in 1 CARTON (63940-119-53) > 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2017-07-280000-00-00NoNoCurrent