MECLIZINE HYDROCHLORIDE

Product NDC
50090-7416
11-digit product format
500907416
Labeler code
50090
Product ID
50090-7416_5c051561-d0cd-47ac-a5c4-b059d3db83b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202640
Marketing category
ANDA
Marketing start
2023-09-14
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
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7416-2MECLIZINE HYDROCHLORIDE12 in 1 BOTTLETABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7416-2EA - Each50090-741629c6dcd3-aaa1-41d7-944b-788eef0f69bf12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7416MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241031_949f7347-8c3a-43ce-b975-8d187096f09f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN949f7347-8c3a-43ce-b975-8d187096f09f1
995666meclizine hydrochloride 25 MG Oral TabletSCD949f7347-8c3a-43ce-b975-8d187096f09f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7416-25009074160212 TABLET in 1 BOTTLE (50090-7416-2) 12 tablet2024-10-28NoNoCurrent