FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
59651-807
11-digit product format
596510807
Labeler code
59651
Product ID
59651-807_beb3c7f2-c0f4-41d9-a903-63a6847e0997
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202640
Marketing category
ANDA
Marketing start
2023-09-14
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 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 HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624, 995666, 995686

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
59651-807-01MECLIZINE HYDROCHLORIDE100 in 1 BOTTLETABLET1001
59651-807-99MECLIZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-807-01EA - Each59651-807237591d7-1b1c-42d8-aee7-85caaecda5a012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-807MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20230920_beb3c7f2-c0f4-41d9-a903-63a6847e0997.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN1a33dec1-8d59-48bd-aaef-77d162194d571
995624meclizine HCl 12.5 MG Oral TabletPSNbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995666meclizine HCl 25 MG Oral TabletPSN1a33dec1-8d59-48bd-aaef-77d162194d571
995666meclizine HCl 25 MG Oral TabletPSNbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995686meclizine HCl 50 MG Oral TabletPSNbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995624meclizine hydrochloride 12.5 MG Oral TabletSCD1a33dec1-8d59-48bd-aaef-77d162194d571
995624meclizine hydrochloride 12.5 MG Oral TabletSCDbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995666meclizine hydrochloride 25 MG Oral TabletSCD1a33dec1-8d59-48bd-aaef-77d162194d571
995666meclizine hydrochloride 25 MG Oral TabletSCDbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995686meclizine hydrochloride 50 MG Oral TabletSCDbeb3c7f2-c0f4-41d9-a903-63a6847e09971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-807-0159651080701100 TABLET in 1 BOTTLE (59651-807-01) 100 tablet2023-09-14NoNoHistorical
59651-807-99596510807991000 TABLET in 1 BOTTLE (59651-807-99) 1000 tablet2023-09-14NoNoHistorical