FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
51655-134
11-digit product format
516550134
Labeler code
51655
Product ID
51655-134_fedb3c26-084b-4741-82e0-4e78ed60a8ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA087128
Marketing category
ANDA
Marketing start
2015-02-26
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
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
51655-134-522026-01-07C16284748780-19d75b9d0-02da-f424-e053-dadaa90a57ce215af966-1ab0-4c47-bcc8-c21e670a26e6
51655-134-522020-01-31C16284748780-19d75b9d0-02da-f424-e053-dadaa90a57ce215af966-1ab0-4c47-bcc8-c21e670a26e6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-134MECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20150323_215af966-1ab0-4c47-bcc8-c21e670a26e6.zip