Meclizine Hydrochloride

Product NDC
42708-127
11-digit product format
427080127
Labeler code
42708
Product ID
42708-127_459bfdd2-c97a-ba9e-e063-6394a90a5d43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
QPharma Inc
Application
ANDA201451
Marketing category
ANDA
Marketing start
2010-02-12
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-127-30Meclizine Hydrochloride30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-127MECLIZINE HYDROCHLORIDE TABLET [QPHARMA INC]5Current NDC, Legacy NDC, 1 package rows20240517_18fe5e13-5583-45ee-ab6e-32e9af426bd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN18fe5e13-5583-45ee-ab6e-32e9af426bd86
995666meclizine hydrochloride 25 MG Oral TabletSCD18fe5e13-5583-45ee-ab6e-32e9af426bd86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42708-127-304270801273030 TABLET in 1 BOTTLE (42708-127-30) 30 tablet2018-05-230000-00-00YesNoCurrent