FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
53746-442
11-digit product format
537460442
Labeler code
53746
Product ID
53746-442_d4732fb5-fb04-4933-8ecc-98ab55184b54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA201451
Marketing category
ANDA
Marketing start
2022-04-22
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine Hydrochloride
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-442-01Meclizine Hydrochloride100 in 1 BOTTLETABLET1004
53746-442-10Meclizine Hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-442-01EA - Each53746-44295b55b48-d25f-45bc-a6c6-e84807886e9812022-10-06
53746-442-10EA - Each53746-442f582f9e0-dbbc-44d9-ba96-58a8f20a337a12022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-442MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]3Current NDC, Legacy NDC, 2 package rows20240114_ff719d9c-8d80-42db-97a5-022a75773623.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNaf5d0c9b-a997-8033-afca-3c04221f2e7611
995666meclizine HCl 25 MG Oral TabletPSNaf5d0c9b-a997-8033-afca-3c04221f2e7611
995624meclizine hydrochloride 12.5 MG Oral TabletSCDaf5d0c9b-a997-8033-afca-3c04221f2e7611
995666meclizine hydrochloride 25 MG Oral TabletSCDaf5d0c9b-a997-8033-afca-3c04221f2e7611
995666meclizine HCl 25 MG Oral TabletPSN2df6edde-4479-ed9d-e063-6394a90abdc16
995666meclizine hydrochloride 25 MG Oral TabletSCD2df6edde-4479-ed9d-e063-6394a90abdc16
995624meclizine HCl 12.5 MG Oral TabletPSNaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995624meclizine HCl 12.5 MG Oral TabletPSNf99f13ab-33c0-4304-8dc5-3a75f39093775
995666meclizine HCl 25 MG Oral TabletPSNaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995666meclizine HCl 25 MG Oral TabletPSNf99f13ab-33c0-4304-8dc5-3a75f39093775
995624meclizine hydrochloride 12.5 MG Oral TabletSCDf99f13ab-33c0-4304-8dc5-3a75f39093775
995624meclizine hydrochloride 12.5 MG Oral TabletSCDaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995666meclizine hydrochloride 25 MG Oral TabletSCDaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995666meclizine hydrochloride 25 MG Oral TabletSCDf99f13ab-33c0-4304-8dc5-3a75f39093775
995624meclizine HCl 12.5 MG Oral TabletPSNff719d9c-8d80-42db-97a5-022a757736234
995666meclizine HCl 25 MG Oral TabletPSNff719d9c-8d80-42db-97a5-022a757736234
995624meclizine hydrochloride 12.5 MG Oral TabletSCDff719d9c-8d80-42db-97a5-022a757736234
995666meclizine hydrochloride 25 MG Oral TabletSCDff719d9c-8d80-42db-97a5-022a757736234
995666meclizine HCl 25 MG Oral TabletPSN1b541252-e8a7-b678-e063-6394a90a34dc3
995666meclizine hydrochloride 25 MG Oral TabletSCD1b541252-e8a7-b678-e063-6394a90a34dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-442-0153746044201100 TABLET in 1 BOTTLE (53746-442-01) 100 tablet2022-04-220000-00-00NoNoCurrent
53746-442-10537460442101000 TABLET in 1 BOTTLE (53746-442-10) 1000 tablet2022-04-220000-00-00NoNoCurrent