FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
71335-1825
11-digit product format
713351825
Labeler code
71335
Product ID
71335-1825_e1e6f9e4-9b01-4878-86ee-fc6c38b61932
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA010721
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-15
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
71335-1825-0Meclizine Hydrochloride14 in 1 BOTTLETABLET14102
71335-1825-1Meclizine Hydrochloride90 in 1 BOTTLETABLET90102
71335-1825-2Meclizine Hydrochloride30 in 1 BOTTLETABLET30102
71335-1825-3Meclizine Hydrochloride25 in 1 BOTTLETABLET25102
71335-1825-4Meclizine Hydrochloride20 in 1 BOTTLETABLET20102
71335-1825-5Meclizine Hydrochloride40 in 1 BOTTLETABLET40102
71335-1825-6Meclizine Hydrochloride60 in 1 BOTTLETABLET60102
71335-1825-7Meclizine Hydrochloride120 in 1 BOTTLETABLET120102
71335-1825-8Meclizine Hydrochloride10 in 1 BOTTLETABLET10102
71335-1825-9Meclizine Hydrochloride100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1825-2EA - Each71335-1825d3b2094c-f9af-4a0c-b2a0-d7ab7f2fdc6212026-01-08
71335-1825-8EA - Each71335-18254efb9eab-8187-4f9c-bac7-2b729d4bf22012026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1825MECLIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20230331_27b6a7e0-a361-4705-9f31-719063a65f22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN27b6a7e0-a361-4705-9f31-719063a65f22102
995666meclizine hydrochloride 25 MG Oral TabletSCD27b6a7e0-a361-4705-9f31-719063a65f22102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1825-07133518250014 TABLET in 1 BOTTLE (71335-1825-0) 14 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-17133518250190 TABLET in 1 BOTTLE (71335-1825-1) 90 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-27133518250230 TABLET in 1 BOTTLE (71335-1825-2) 30 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-37133518250325 TABLET in 1 BOTTLE (71335-1825-3) 25 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-47133518250420 TABLET in 1 BOTTLE (71335-1825-4) 20 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-57133518250540 TABLET in 1 BOTTLE (71335-1825-5) 40 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-67133518250660 TABLET in 1 BOTTLE (71335-1825-6) 60 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-771335182507120 TABLET in 1 BOTTLE (71335-1825-7) 120 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-87133518250810 TABLET in 1 BOTTLE (71335-1825-8) 10 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-971335182509100 TABLET in 1 BOTTLE (71335-1825-9) 100 tablet2022-02-240000-00-00NoNoCurrent