Meclizine HCl

Product NDC
57237-333
11-digit product format
572370333
Labeler code
57237
Product ID
57237-333_f603203c-84a4-4b41-a244-cff913e5c2e0
Type
HUMAN OTC DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M009.50
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-22
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
57237-333-01Meclizine HCl100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-333-01EA - Each57237-3334687908e-e794-453c-adee-a9b75d405bc312024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-333MECLIZINE HCL (MECLIZINE HYDROCHLORIDE) TABLET [RISING PHARMA HOLDINGS, INC.]3Current NDC, 1 package rows20241116_acdf636c-66f1-4a1f-87a8-786f51d75708.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNacdf636c-66f1-4a1f-87a8-786f51d757083
995624meclizine hydrochloride 12.5 MG Oral TabletSCDacdf636c-66f1-4a1f-87a8-786f51d757083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-333-0157237033301100 TABLET in 1 BOTTLE (57237-333-01) 100 tablet2024-07-22NoNoCurrent