MECLIZINE HYDROCHLORIDE

Product NDC
61919-886
11-digit product format
619190886
Labeler code
61919
Product ID
61919-886_f216106d-2257-fc25-e053-2a95a90aeff8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040659
Marketing category
ANDA
Marketing start
2019-08-01
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
13 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2024-12-31
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
61919-886-302025-01-30C16284748780-12cef2736-8964-d83d-e063-dadaa90ab31fMECLIZINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-886-30MECLIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-886-30EA - Each61919-8867b49d86c-3f6f-4667-aac0-ab87b71a991612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-886MECLIZINE HYDROCHLORIDE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20230113_8f0e62c6-6e50-56a8-e053-2995a90a4a38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN8f0e62c6-6e50-56a8-e053-2995a90a4a382
995624meclizine hydrochloride 12.5 MG Oral TabletSCD8f0e62c6-6e50-56a8-e053-2995a90a4a382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-886-306191908863030 TABLET in 1 BOTTLE (61919-886-30) 30 tablet2019-08-010000-00-00NoNoCurrent