Meclizine Hydrochloride

Product NDC
50268-523
11-digit product format
502680523
Labeler code
50268
Product ID
50268-523_47e73600-a8db-31d6-e063-6294a90a47f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA201451
Marketing category
ANDA
Marketing start
2013-08-08
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624, 995666

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
50268-523-11Meclizine Hydrochloride1 in 1 BLISTER PACKTABLET111
50268-523-15Meclizine Hydrochloride50 in 1 BOX, UNIT-DOSETABLET5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-523-11EA - Each50268-523f0ffa279-5d22-44f5-a080-4ae8f86aaccb12015-04-03
50268-523-15EA - Each50268-523c1ed8fe7-b1e6-4cf6-9bca-43e79d4b8b2112013-10-17

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-523MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET MECLIZINE HYDROCHLORIDE TABLET [AVPAK]10Current NDC, Legacy NDC, 2 package rows20231027_af5d0c9b-a997-8033-afca-3c04221f2e76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNaf5d0c9b-a997-8033-afca-3c04221f2e7611
995666meclizine HCl 25 MG Oral TabletPSNaf5d0c9b-a997-8033-afca-3c04221f2e7611
995624meclizine hydrochloride 12.5 MG Oral TabletSCDaf5d0c9b-a997-8033-afca-3c04221f2e7611
995666meclizine hydrochloride 25 MG Oral TabletSCDaf5d0c9b-a997-8033-afca-3c04221f2e7611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-523-11502680523111 in 1 BLISTER PACKHistorical
50268-523-155026805231550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-523-15) / 1 TABLET in 1 BLISTER PACK (50268-523-11) 50 blister pack2013-08-080000-00-00NoNoCurrent