FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
65162-441
11-digit product format
651620441
Labeler code
65162
Product ID
65162-441_50a794d1-8c02-4419-a037-de9d3825d342
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA201451
Marketing category
ANDA
Marketing start
2010-02-12
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 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 HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624, 995666, 995686

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
65162-441-032023-03-21C16284748780-1f386c64a-0b04-0266-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
65162-441-102023-03-21C16284748780-1f386c64a-0b04-0266-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
65162-441-112023-03-21C16284748780-1f386c64a-0b04-0266-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
65162-441-502023-03-21C16284748780-1f386c64a-0b04-0266-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
65162-441-602023-03-21C16284748780-1f386c64a-0b04-0266-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
65162-441-032023-01-30C16284748780-1f386c64a-0b04-0266-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
65162-441-102023-01-30C16284748780-1f386c64a-0b04-0266-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
65162-441-112023-01-30C16284748780-1f386c64a-0b04-0266-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
65162-441-502023-01-30C16284748780-1f386c64a-0b04-0266-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
65162-441-602023-01-30C16284748780-1f386c64a-0b04-0266-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
65162-441-03Meclizine Hydrochloride30 in 1 BOTTLETABLET3020
65162-441-10Meclizine Hydrochloride100 in 1 BOTTLETABLET10020
65162-441-11Meclizine Hydrochloride1000 in 1 BOTTLETABLET100020
65162-441-50Meclizine Hydrochloride500 in 1 BOTTLETABLET50020
65162-441-60Meclizine Hydrochloride100 in 1 BLISTER PACKTABLET10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-441-10EA - Each65162-4410dcde44e-cef5-4904-ba69-aebe3ad57b2d12012-07-24
65162-441-11EA - Each65162-4412c960c04-eec9-4d73-bb6e-4de65d071fc412012-07-24
65162-441-50EA - Each65162-441aba65022-b917-4bc3-ae0e-670ab444053912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6
TALCINACTIVE INGREDIENT7SEV7J4R1UMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-441MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC]20Current NDC, Legacy NDC, 5 package rows20241030_666dc4d8-7b16-4c3c-84e4-645548dbee68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN666dc4d8-7b16-4c3c-84e4-645548dbee6820
995666meclizine HCl 25 MG Oral TabletPSN666dc4d8-7b16-4c3c-84e4-645548dbee6820
995686meclizine HCl 50 MG Oral TabletPSN666dc4d8-7b16-4c3c-84e4-645548dbee6820
995624meclizine hydrochloride 12.5 MG Oral TabletSCD666dc4d8-7b16-4c3c-84e4-645548dbee6820
995666meclizine hydrochloride 25 MG Oral TabletSCD666dc4d8-7b16-4c3c-84e4-645548dbee6820
995686meclizine hydrochloride 50 MG Oral TabletSCD666dc4d8-7b16-4c3c-84e4-645548dbee6820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-441-036516204410330 TABLET in 1 BOTTLE (65162-441-03) 30 tablet2010-02-120000-00-00NoNoCurrent
65162-441-1065162044110100 TABLET in 1 BOTTLE (65162-441-10) 100 tablet2010-02-120000-00-00NoNoCurrent
65162-441-11651620441111000 TABLET in 1 BOTTLE (65162-441-11) 1000 tablet2010-02-120000-00-00NoNoCurrent
65162-441-5065162044150500 TABLET in 1 BOTTLE (65162-441-50) 500 tablet2010-02-120000-00-00NoNoCurrent
65162-441-6065162044160100 TABLET in 1 BLISTER PACK (65162-441-60) 100 tablet2010-02-120000-00-00NoNoCurrent