Meclizine Hydrochloride

Product NDC
50436-3988
11-digit product format
504363988
Labeler code
50436
Product ID
50436-3988_2e9294f8-ef0b-40e2-a73c-13489d63fcd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meclizine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA087128
Marketing category
ANDA
Marketing start
1981-06-03
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-3988-12021-01-29C16284748780-1ba0f9c33-0df9-a910-e053-dadaa90a0b85Rx Only
50436-3988-32021-01-29C16284748780-1ba0f9c33-0df9-a910-e053-dadaa90a0b85Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3988-1Meclizine Hydrochloride30 in 1 BOTTLETABLET305
50436-3988-3Meclizine Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3988-1EA - Each50436-398857db07d0-e97d-45d6-9c4b-cc2ee3cdd43012014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RMECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3988MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]5Legacy NDC, 2 package rows20171109_036f8929-ad15-4bfd-96d2-c2541170500b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN036f8929-ad15-4bfd-96d2-c2541170500b5
995666meclizine hydrochloride 25 MG Oral TabletSCD036f8929-ad15-4bfd-96d2-c2541170500b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3988-15043639880130 in 1 BOTTLEHistorical
50436-3988-35043639880390 in 1 BOTTLEHistorical