FDA.reportPublic FDA data

Clemastine Fumarate

Product NDC
51655-425
11-digit product format
516550425
Labeler code
51655
Product ID
51655-425_82dfc095-30e3-441a-a9b6-5276a049f5a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clemastine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA073283
Marketing category
ANDA
Marketing start
2014-04-28
Marketing end
0000-00-00
Substance
CLEMASTINE FUMARATE
Active strength
3 mg/1
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
51655-425-042026-01-13C16284748780-19d75b9d0-1bcd-f424-e053-dadaa90a57cebe4f8613-e4da-45e1-a5c0-e9337ca5d245
51655-425-042020-01-31C16284748780-19d75b9d0-1bcd-f424-e053-dadaa90a57cebe4f8613-e4da-45e1-a5c0-e9337ca5d245

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLEMASTINE FUMARATEACTIVE INGREDIENT19259EGQ3DCLEMASTINE FUMARATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CLEMASTINEACTIVE MOIETY95QN29S1IDCLEMASTINE FUMARATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-425CLEMASTINE FUMARATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20140721_be4f8613-e4da-45e1-a5c0-e9337ca5d245.zip