FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
59746-122
11-digit product format
597460122
Labeler code
59746
Product ID
59746-122_ead33f00-e158-464f-953f-ab5a9a391199
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
Marketing end
2026-10-31
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624, 995666

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
59746-122-062025-07-31C16284748780-12cef2736-74a4-d83d-e063-dadaa90ab31fThese 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 Rx Only Initial U.S. Approval: 1957
59746-122-102025-07-31C16284748780-12cef2736-74a4-d83d-e063-dadaa90ab31fThese 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 Rx Only Initial U.S. Approval: 1957
59746-122-062025-01-30C16284748780-12cef2736-74a4-d83d-e063-dadaa90ab31fThese 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 Rx Only Initial U.S. Approval: 1957
59746-122-102025-01-30C16284748780-12cef2736-74a4-d83d-e063-dadaa90ab31fThese 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 Rx Only Initial U.S. Approval: 1957

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-122-06MECLIZINE HYDROCHLORIDE100 in 1 BOTTLETABLET1008
59746-122-10MECLIZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-122-06EA - Each59746-122401b9f3f-d39c-432e-a7d8-ddf93576153a12012-07-24
59746-122-10EA - Each59746-12214b905d9-2e92-4361-9822-8693ebcc58c612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-122MECLIZINE HYDROCHLORIDE TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20191221_9350fefc-9c00-182c-c3a9-044d4a40856f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN6c66ee38-10bb-4559-9d2f-51e6d6f091ee103
995624meclizine hydrochloride 12.5 MG Oral TabletSCD6c66ee38-10bb-4559-9d2f-51e6d6f091ee103
995624meclizine HCl 12.5 MG Oral TabletPSN522b55a2-313c-45e8-b1be-07746ada5b0a101
995624meclizine hydrochloride 12.5 MG Oral TabletSCD522b55a2-313c-45e8-b1be-07746ada5b0a101
995624meclizine HCl 12.5 MG Oral TabletPSN6dd657ba-46dc-4106-9f6a-dfa0ecf8575213
995624meclizine hydrochloride 12.5 MG Oral TabletSCD6dd657ba-46dc-4106-9f6a-dfa0ecf8575213
995624meclizine HCl 12.5 MG Oral TabletPSN9350fefc-9c00-182c-c3a9-044d4a40856f8
995666meclizine HCl 25 MG Oral TabletPSN9350fefc-9c00-182c-c3a9-044d4a40856f8
995624meclizine hydrochloride 12.5 MG Oral TabletSCD9350fefc-9c00-182c-c3a9-044d4a40856f8
995666meclizine hydrochloride 25 MG Oral TabletSCD9350fefc-9c00-182c-c3a9-044d4a40856f8
995624meclizine HCl 12.5 MG Oral TabletPSN8f0e62c6-6e50-56a8-e053-2995a90a4a382
995624meclizine HCl 12.5 MG Oral TabletPSN6a8cbc12-0725-4462-bb71-0b18cefc19e72
995624meclizine hydrochloride 12.5 MG Oral TabletSCD8f0e62c6-6e50-56a8-e053-2995a90a4a382
995624meclizine hydrochloride 12.5 MG Oral TabletSCD6a8cbc12-0725-4462-bb71-0b18cefc19e72
995624meclizine HCl 12.5 MG Oral TabletPSN53f410fd-104c-42c1-9740-6f48ffbc974f1
995624meclizine HCl 12.5 MG Oral TabletPSNb4f4fc27-0205-4eab-97ab-d79fa6dbf3061
995624meclizine HCl 12.5 MG Oral TabletPSNf673387f-0b94-42e5-9747-60bc80de93e51
995624meclizine hydrochloride 12.5 MG Oral TabletSCD53f410fd-104c-42c1-9740-6f48ffbc974f1
995624meclizine hydrochloride 12.5 MG Oral TabletSCDb4f4fc27-0205-4eab-97ab-d79fa6dbf3061
995624meclizine hydrochloride 12.5 MG Oral TabletSCDf673387f-0b94-42e5-9747-60bc80de93e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-122-0659746012206100 TABLET in 1 BOTTLE (59746-122-06) 100 tablet2010-06-042026-10-31NoNoCurrent
59746-122-10597460122101000 TABLET in 1 BOTTLE (59746-122-10) 1000 tablet2010-06-042026-10-31NoNoCurrent