Meclizine Hydrochloride

Product NDC
63187-258
11-digit product format
631870258
Labeler code
63187
Product ID
63187-258_9a01be91-ff05-4f46-92d4-68b2d1db251c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200294
Marketing category
ANDA
Marketing start
2012-04-30
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995666

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-258-10Meclizine Hydrochloride10 in 1 BOTTLETABLET105
63187-258-20Meclizine Hydrochloride20 in 1 BOTTLETABLET205
63187-258-30Meclizine Hydrochloride30 in 1 BOTTLETABLET305
63187-258-60Meclizine Hydrochloride60 in 1 BOTTLETABLET605
63187-258-90Meclizine Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-258MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 5 package rows20210116_91b1fd1a-1da2-4aae-826f-7de0bfe62161.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN91b1fd1a-1da2-4aae-826f-7de0bfe621615
995666meclizine hydrochloride 25 MG Oral TabletSCD91b1fd1a-1da2-4aae-826f-7de0bfe621615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-258-106318702581010 TABLET in 1 BOTTLE (63187-258-10) 10 tablet2019-01-010000-00-00NoNoCurrent
63187-258-206318702582020 TABLET in 1 BOTTLE (63187-258-20) 20 tablet2019-01-010000-00-00NoNoCurrent
63187-258-306318702583030 TABLET in 1 BOTTLE (63187-258-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-258-606318702586060 TABLET in 1 BOTTLE (63187-258-60) 60 tablet2019-01-010000-00-00NoNoCurrent
63187-258-906318702589090 TABLET in 1 BOTTLE (63187-258-90) 90 tablet2019-01-010000-00-00NoNoCurrent