FDA.reportPublic FDA data

Loperamide hydrochloride

Product NDC
51655-547
11-digit product format
516550547
Labeler code
51655
Product ID
51655-547_507afe22-33ab-4fc5-95c7-74dfd5dda6cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loperamide hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA073192
Marketing category
ANDA
Marketing start
2014-10-22
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-547-302026-01-07C16284748780-19d75b9d0-656b-f424-e053-dadaa90a57ce3f7e5f53-e587-411b-a0ec-b32452ec0d21
51655-547-302020-01-31C16284748780-19d75b9d0-656b-f424-e053-dadaa90a57ce3f7e5f53-e587-411b-a0ec-b32452ec0d21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-547LOPERAMIDE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20141031_3f7e5f53-e587-411b-a0ec-b32452ec0d21.zip