Meclizine Hydrochloride

Product NDC
70518-3768
11-digit product format
705183768
Labeler code
70518
Product ID
70518-3768_4f84344b-5a64-4df9-e063-6394a90a040c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA010721
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-06-19
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 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 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
70518-3768-0Meclizine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3768MECLIZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]2Current NDC, 1 package rows20240331_d53bf04e-5cfc-4974-9b24-2cce545d1bd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNd53bf04e-5cfc-4974-9b24-2cce545d1bd04
995624meclizine hydrochloride 12.5 MG Oral TabletSCDd53bf04e-5cfc-4974-9b24-2cce545d1bd04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3768-07051837680030 TABLET in 1 BOTTLE, PLASTIC (70518-3768-0) 30 tablet2023-06-19NoNoCurrent