Meclizine Hydrochloride

Product NDC
42708-189
11-digit product format
427080189
Labeler code
42708
Product ID
42708-189_5190c80c-4f19-1c04-e063-6294a90aefcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
QPharma Inc
Application
ANDA201451
Marketing category
ANDA
Marketing start
2022-04-22
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
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
42708-189-30Meclizine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-189MECLIZINE HYDROCHLORIDE TABLET [QPHARMA INC]1Current NDC, 1 package rows20250215_2df6edde-4479-ed9d-e063-6394a90abdc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN2df6edde-4479-ed9d-e063-6394a90abdc16
995666meclizine hydrochloride 25 MG Oral TabletSCD2df6edde-4479-ed9d-e063-6394a90abdc16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42708-189-304270801893030 TABLET in 1 BOTTLE, PLASTIC (42708-189-30) 30 tablet2025-02-15YesNoCurrent