FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
59746-121
11-digit product format
597460121
Labeler code
59746
Product ID
59746-121_ead33f00-e158-464f-953f-ab5a9a391199
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrocloride
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
25 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 HYDROCHLORIDE25 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
59746-121-062025-07-31C16284748780-12cef2736-74a4-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
59746-121-102025-07-31C16284748780-12cef2736-74a4-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
59746-121-062025-01-30C16284748780-12cef2736-74a4-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
59746-121-102025-01-30C16284748780-12cef2736-74a4-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
59746-121-06MECLIZINE HYDROCHLORIDE100 in 1 BOTTLETABLET1008
59746-121-10MECLIZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-121-06EA - Each59746-121426b1544-2026-4b5e-92b6-b06bf4ad888312012-07-24
59746-121-10EA - Each59746-121ef373495-c09a-4243-9246-5944249609e512012-07-24

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
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Meclizine HydrochlorideACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
MeclizineACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, 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 HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, 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
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, 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
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [BLENHEIM PHARMACAL, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]2
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [LIFE LINE HOME CARE SERVICES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-121MECLIZINE 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
995666meclizine HCl 25 MG Oral TabletPSNf43bf077-3f29-48ec-8ca8-eb294dbf2001101
995666meclizine hydrochloride 25 MG Oral TabletSCDf43bf077-3f29-48ec-8ca8-eb294dbf2001101
995666meclizine HCl 25 MG Oral TabletPSNba2fb6de-af86-4c05-9018-135e1f8594f919
995666meclizine hydrochloride 25 MG Oral TabletSCDba2fb6de-af86-4c05-9018-135e1f8594f919
995666meclizine HCl 25 MG Oral TabletPSNea4a354b-05fe-47b4-9e96-bc7b5c4cadf29
995666meclizine HCl 25 MG Oral TabletPSN648570f0-2def-4d15-87bc-ca631439e7f49
995666meclizine hydrochloride 25 MG Oral TabletSCDea4a354b-05fe-47b4-9e96-bc7b5c4cadf29
995666meclizine hydrochloride 25 MG Oral TabletSCD648570f0-2def-4d15-87bc-ca631439e7f49
995624meclizine HCl 12.5 MG Oral TabletPSN9350fefc-9c00-182c-c3a9-044d4a40856f8
995666meclizine HCl 25 MG Oral TabletPSN4e3ca2b3-8e1e-439f-e054-00144ff88e888
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 TabletSCD4e3ca2b3-8e1e-439f-e054-00144ff88e888
995666meclizine hydrochloride 25 MG Oral TabletSCD9350fefc-9c00-182c-c3a9-044d4a40856f8
995666meclizine HCl 25 MG Oral TabletPSNf574e123-8db7-4e3d-a0ee-e4e1f04ff1466
995666meclizine hydrochloride 25 MG Oral TabletSCDf574e123-8db7-4e3d-a0ee-e4e1f04ff1466
995666meclizine HCl 25 MG Oral TabletPSN64a508ae-768a-2fba-e053-2991aa0ac42d5
995666meclizine HCl 25 MG Oral TabletPSNaa0fb895-a867-4482-9bc2-16eee8bfaaa05
995666meclizine HCl 25 MG Oral TabletPSNc443873a-2e89-43b2-b145-dde3dadf7bc05
995666meclizine HCl 25 MG Oral TabletPSNe340262a-4018-4b5b-a580-ead858907b125
995666meclizine hydrochloride 25 MG Oral TabletSCD64a508ae-768a-2fba-e053-2991aa0ac42d5
995666meclizine hydrochloride 25 MG Oral TabletSCDaa0fb895-a867-4482-9bc2-16eee8bfaaa05
995666meclizine hydrochloride 25 MG Oral TabletSCDc443873a-2e89-43b2-b145-dde3dadf7bc05
995666meclizine hydrochloride 25 MG Oral TabletSCDe340262a-4018-4b5b-a580-ead858907b125
995666meclizine HCl 25 MG Oral TabletPSN90a236e0-4a1a-f755-e053-2a95a90a08c32
995666meclizine HCl 25 MG Oral TabletPSN1167fc42-ed45-2c39-e054-00144ff88e882
995666meclizine HCl 25 MG Oral TabletPSN180aedec-8a48-4e56-8eed-7daff874161b2
995666meclizine hydrochloride 25 MG Oral TabletSCD1167fc42-ed45-2c39-e054-00144ff88e882
995666meclizine hydrochloride 25 MG Oral TabletSCD90a236e0-4a1a-f755-e053-2a95a90a08c32
995666meclizine hydrochloride 25 MG Oral TabletSCD180aedec-8a48-4e56-8eed-7daff874161b2
995666meclizine HCl 25 MG Oral TabletPSN04a7609c-45a7-412b-ba0e-e2de689ba1011
995666meclizine HCl 25 MG Oral TabletPSNe6a5b78d-1939-4632-ab83-90ca169e56e41
995666meclizine HCl 25 MG Oral TabletPSN478bac81-1b81-4c8e-b894-019c5a039b6d1
995666meclizine HCl 25 MG Oral TabletPSN5c70e61b-a1e6-4981-92e2-1050cee08baa1
995666meclizine HCl 25 MG Oral TabletPSN8fecbf38-56be-2323-e053-2995a90a78381
995666meclizine hydrochloride 25 MG Oral TabletSCDe6a5b78d-1939-4632-ab83-90ca169e56e41
995666meclizine hydrochloride 25 MG Oral TabletSCD478bac81-1b81-4c8e-b894-019c5a039b6d1
995666meclizine hydrochloride 25 MG Oral TabletSCD5c70e61b-a1e6-4981-92e2-1050cee08baa1
995666meclizine hydrochloride 25 MG Oral TabletSCD04a7609c-45a7-412b-ba0e-e2de689ba1011
995666meclizine hydrochloride 25 MG Oral TabletSCD8fecbf38-56be-2323-e053-2995a90a78381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-121-0659746012106100 TABLET in 1 BOTTLE (59746-121-06) 100 tablet2010-06-042026-10-31NoNoCurrent
59746-121-10597460121101000 TABLET in 1 BOTTLE (59746-121-10) 1000 tablet2010-06-042026-10-31NoNoCurrent