Meclizine HCl

Product NDC
68001-528
11-digit product format
680010528
Labeler code
68001
Product ID
68001-528_097bfb09-4450-bd70-e063-6294a90a91b7
Type
HUMAN OTC DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-14
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 HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624

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
68001-528-00Meclizine HCl100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-528MECLIZINE HCL (MECLIZINE HYDROCHLORIDE) TABLET [BLUEPOINT LABORATORIES]2Current NDC, Legacy NDC, 1 package rows20231118_d9cae5a6-8d4b-bdaf-e053-2995a90a7d44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNd9cae5a6-8d4b-bdaf-e053-2995a90a7d442
995624meclizine hydrochloride 12.5 MG Oral TabletSCDd9cae5a6-8d4b-bdaf-e053-2995a90a7d442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-528-0068001052800100 TABLET in 1 BOTTLE (68001-528-00) 100 tablet2022-03-140000-00-00NoNoCurrent