FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
63187-996
11-digit product format
631870996
Labeler code
63187
Product ID
63187-996_6d44d894-810c-4608-a503-0cc6ff1f965d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrocloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
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
63187-996-10MECLIZINE HYDROCHLORIDE10 in 1 BOTTLETABLET106
63187-996-20MECLIZINE HYDROCHLORIDE20 in 1 BOTTLETABLET206
63187-996-30MECLIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET306
63187-996-60MECLIZINE HYDROCHLORIDE60 in 1 BOTTLETABLET606
63187-996-90MECLIZINE HYDROCHLORIDE90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-996MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 5 package rows20220701_f574e123-8db7-4e3d-a0ee-e4e1f04ff146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNf574e123-8db7-4e3d-a0ee-e4e1f04ff1466
995666meclizine hydrochloride 25 MG Oral TabletSCDf574e123-8db7-4e3d-a0ee-e4e1f04ff1466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-996-106318709961010 TABLET in 1 BOTTLE (63187-996-10) 10 tablet2020-05-120000-00-00NoNoCurrent
63187-996-206318709962020 TABLET in 1 BOTTLE (63187-996-20) 20 tablet2018-03-010000-00-00NoNoCurrent
63187-996-306318709963030 TABLET in 1 BOTTLE (63187-996-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-996-606318709966060 TABLET in 1 BOTTLE (63187-996-60) 60 tablet2022-06-170000-00-00NoNoCurrent
63187-996-906318709969090 TABLET in 1 BOTTLE (63187-996-90) 90 tablet2022-06-170000-00-00NoNoCurrent