FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
50090-5728
11-digit product format
500905728
Labeler code
50090
Product ID
50090-5728_154a8e7e-94cf-413f-9a2b-5f07b7bfa61c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213957
Marketing category
ANDA
Marketing start
2020-10-29
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995666

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
50090-5728-02023-02-06C16284748780-1f386c649-d019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1957
50090-5728-12023-02-06C16284748780-1f386c649-d019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1957
50090-5728-42023-02-06C16284748780-1f386c649-d019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1957
50090-5728-82023-02-06C16284748780-1f386c649-d019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1957
50090-5728-02023-01-30C16284748780-1f386c649-d019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1957
50090-5728-12023-01-30C16284748780-1f386c649-d019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1957
50090-5728-42023-01-30C16284748780-1f386c649-d019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1957
50090-5728-82023-01-30C16284748780-1f386c649-d019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MECLIZINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MECLIZINE HYDROCHLORIDE TABLETS. MECLIZINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1957

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5728-0Meclizine Hydrochloride20 in 1 BOTTLETABLET207
50090-5728-1Meclizine Hydrochloride30 in 1 BOTTLETABLET307
50090-5728-4Meclizine Hydrochloride10 in 1 BOTTLETABLET107
50090-5728-8Meclizine Hydrochloride90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5728-0EA - Each50090-5728ee18ae51-12eb-47c3-a38c-6813591dc10812022-08-04
50090-5728-1EA - Each50090-5728cd55a59a-36f0-4424-a9a8-e0ea9fd2766612022-08-04
50090-5728-4EA - Each50090-57284af769f3-316e-4764-972c-e238d979ae6712022-08-04
50090-5728-8EA - Each50090-572847a0ac06-9668-45f3-8d60-7c078a21017912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5728MECLIZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 4 package rows20231204_eae4bc73-fee1-4831-b31c-8ca56fb83ad7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNeae4bc73-fee1-4831-b31c-8ca56fb83ad77
995666meclizine hydrochloride 25 MG Oral TabletSCDeae4bc73-fee1-4831-b31c-8ca56fb83ad77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5728-05009057280020 TABLET in 1 BOTTLE (50090-5728-0) 20 tablet2021-09-280000-00-00NoNoCurrent
50090-5728-15009057280130 TABLET in 1 BOTTLE (50090-5728-1) 30 tablet2021-09-280000-00-00NoNoCurrent
50090-5728-45009057280410 TABLET in 1 BOTTLE (50090-5728-4) 10 tablet2021-09-280000-00-00NoNoCurrent
50090-5728-85009057280890 TABLET in 1 BOTTLE (50090-5728-8) 90 tablet2021-09-280000-00-00NoNoCurrent