FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
68071-3017
11-digit product format
680713017
Labeler code
68071
Product ID
68071-3017_1d788e6f-633a-a344-e063-6294a90a90d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrocloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
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
68071-3017-12024-07-17C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-22024-07-17C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-32024-07-17C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-62024-07-17C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-72024-07-17C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-92024-07-17C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-12023-01-30C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-22023-01-30C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-32023-01-30C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-62023-01-30C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-72023-01-30C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-92023-01-30C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-12021-02-11C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-22021-02-11C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-32021-02-11C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-62021-02-11C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-72021-02-11C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-92021-02-11C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-12021-01-29C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-22021-01-29C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-32021-01-29C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-62021-01-29C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-72021-01-29C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only
68071-3017-92021-01-29C16284748780-1ba0f9c33-1bf5-a910-e053-dadaa90a0b85MECLIZINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3017-1MECLIZINE HYDROCHLORIDE12 in 1 BOTTLETABLET125
68071-3017-2MECLIZINE HYDROCHLORIDE20 in 1 BOTTLETABLET205
68071-3017-3MECLIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET305
68071-3017-6MECLIZINE HYDROCHLORIDE60 in 1 BOTTLETABLET605
68071-3017-7MECLIZINE HYDROCHLORIDE10 in 1 BOTTLETABLET105
68071-3017-9MECLIZINE HYDROCHLORIDE90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3017MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 6 package rows20240719_64a508ae-768a-2fba-e053-2991aa0ac42d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN64a508ae-768a-2fba-e053-2991aa0ac42d5
995666meclizine hydrochloride 25 MG Oral TabletSCD64a508ae-768a-2fba-e053-2991aa0ac42d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3017-16807130170112 TABLET in 1 BOTTLE (68071-3017-1) 12 tablet2018-02-070000-00-00NoNoCurrent
68071-3017-26807130170220 TABLET in 1 BOTTLE (68071-3017-2) 20 tablet2018-02-070000-00-00NoNoCurrent
68071-3017-36807130170330 TABLET in 1 BOTTLE (68071-3017-3) 30 tablet2018-02-070000-00-00NoNoCurrent
68071-3017-66807130170660 TABLET in 1 BOTTLE (68071-3017-6) 60 tablet2018-02-070000-00-00NoNoCurrent
68071-3017-76807130170710 TABLET in 1 BOTTLE (68071-3017-7) 10 tablet2018-02-070000-00-00NoNoCurrent
68071-3017-96807130170990 TABLET in 1 BOTTLE (68071-3017-9) 90 tablet2018-02-070000-00-00NoNoCurrent