MECLIZINE HYDROCHLORIDE

Product NDC
53808-1116
11-digit product format
538081116
Labeler code
53808
Product ID
53808-1116_a804d650-9d29-447a-b311-87f1e4b43cab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrocloride
Dosage form
TABLET
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA040659
Marketing category
ANDA
Marketing start
2017-10-26
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1116-12024-01-30C16284748780-11030e365-6694-111a-e063-dadaa90a10e2Meclizine hydrochloride tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1116-1MECLIZINE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1116MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190122_478bac81-1b81-4c8e-b894-019c5a039b6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN478bac81-1b81-4c8e-b894-019c5a039b6d1
995666meclizine hydrochloride 25 MG Oral TabletSCD478bac81-1b81-4c8e-b894-019c5a039b6d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53808-1116-15380811160130 TABLET in 1 BLISTER PACK (53808-1116-1) 30 tablet2017-10-260000-00-00NoNoCurrent