FDA.reportPublic FDA data

MECLIZINE HYDROCHLORIDE

Product NDC
50090-7417
11-digit product format
500907417
Labeler code
50090
Product ID
50090-7417_129bad2d-36ae-482f-a8b0-a574d738216c
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
50090-7417-0MECLIZINE HYDROCHLORIDE20 in 1 BOTTLETABLET202
50090-7417-1MECLIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET302
50090-7417-4MECLIZINE HYDROCHLORIDE10 in 1 BOTTLETABLET102
50090-7417-8MECLIZINE HYDROCHLORIDE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7417-0EA - Each50090-7417b5bd1434-a56c-48a0-af74-b05e4065d60012024-12-10
50090-7417-1EA - Each50090-7417c293e518-beb7-45d5-b5ee-5ade5d7a4ad712024-12-10
50090-7417-4EA - Each50090-7417c8e7c16c-2768-4306-8aa8-e22ebebbece412024-12-10
50090-7417-8EA - Each50090-74177a432117-7b93-434a-aa5f-e035fdfd9ab212024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7417MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [A-S MEDICATION SOLUTIONS]2Current NDC, 4 package rows20241031_55e262d9-d9dd-43a3-bc74-35e46dd391be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN55e262d9-d9dd-43a3-bc74-35e46dd391be2
995666meclizine hydrochloride 25 MG Oral TabletSCD55e262d9-d9dd-43a3-bc74-35e46dd391be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7417-05009074170020 TABLET in 1 BOTTLE (50090-7417-0) 20 tablet2024-10-28NoNoHistorical
50090-7417-15009074170130 TABLET in 1 BOTTLE (50090-7417-1) 30 tablet2024-10-28NoNoHistorical
50090-7417-45009074170410 TABLET in 1 BOTTLE (50090-7417-4) 10 tablet2024-10-28NoNoHistorical
50090-7417-85009074170890 TABLET in 1 BOTTLE (50090-7417-8) 90 tablet2024-10-28NoNoHistorical