FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
50090-0106
11-digit product format
500900106
Labeler code
50090
Product ID
50090-0106_76164bfe-2ea6-421e-8d3f-ca36f917e415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201451
Marketing category
ANDA
Marketing start
2010-02-12
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-0106-02023-01-30C16284748780-1f386c649-e1d7-0266-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
50090-0106-12023-01-30C16284748780-1f386c649-e1d7-0266-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
50090-0106-42023-01-30C16284748780-1f386c649-e1d7-0266-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
50090-0106-82023-01-30C16284748780-1f386c649-e1d7-0266-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
50090-0106-0Meclizine Hydrochloride20 in 1 BOTTLETABLET2021
50090-0106-1Meclizine Hydrochloride30 in 1 BOTTLETABLET3021
50090-0106-4Meclizine Hydrochloride10 in 1 BOTTLETABLET1021
50090-0106-8Meclizine Hydrochloride90 in 1 BOTTLETABLET9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0106-0EA - Each50090-010628e9f90f-1de3-4e82-8411-4f0ea6e4877f12018-08-13
50090-0106-1EA - Each50090-0106a7ecaa85-c676-4c95-953e-fff2e66dde6612018-08-13
50090-0106-4EA - Each50090-01067cedf0e0-cb9c-415c-a8c7-910b60d04ccb12018-08-13
50090-0106-8EA - Each50090-010671dd3b51-a701-4c1a-86f4-c146ff8c1f7712018-08-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0106MECLIZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]21Legacy NDC, 4 package rows20210415_c0dd6732-594a-462a-a67e-26778239984c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNc0dd6732-594a-462a-a67e-26778239984c21
995666meclizine hydrochloride 25 MG Oral TabletSCDc0dd6732-594a-462a-a67e-26778239984c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0106-05009001060020 TABLET in 1 BOTTLE (50090-0106-0) 20 tablet2014-11-280000-00-00NoNoCurrent
50090-0106-15009001060130 TABLET in 1 BOTTLE (50090-0106-1) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0106-45009001060410 TABLET in 1 BOTTLE (50090-0106-4) 10 tablet2014-11-280000-00-00NoNoCurrent
50090-0106-85009001060890 TABLET in 1 BOTTLE (50090-0106-8) 90 tablet2018-05-160000-00-00NoNoCurrent