VERMOX

Product NDC
50458-675
11-digit product format
504580675
Labeler code
50458
Product ID
50458-675_5757cf97-389e-4199-8b53-d32a18e55800
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mebendazole
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA208398
Marketing category
NDA
Marketing start
2016-10-20
Substance
MEBENDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Anthelmintic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VERMOX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEBENDAZOLE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii81G6I5V05I
Rxcui1855385, 1855387

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45321ae1-9b60-45e7-974f-396dda737653Product name120170726
ab9a1f2d-4b9a-4fa2-86c2-2f15e99fbddeProduct name120161208
08712ce3-8f49-4e75-fde7-a7e1f8d69521Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-675-20VERMOX200 in 1 BOTTLETABLET, CHEWABLE2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-675VERMOX (MEBENDAZOLE) TABLET, CHEWABLE [JANSSEN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20211006_a720c424-517a-461b-8e13-6c37caf8aa3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1855385mebendazole 500 MG Chewable TabletPSNa720c424-517a-461b-8e13-6c37caf8aa3f5
1855387Vermox 500 MG Chewable TabletPSNa720c424-517a-461b-8e13-6c37caf8aa3f5
1855387mebendazole 500 MG Chewable Tablet [Vermox]SBDa720c424-517a-461b-8e13-6c37caf8aa3f5
1855385mebendazole 500 MG Chewable TabletSCDa720c424-517a-461b-8e13-6c37caf8aa3f5
1855387Vermox 500 MG Chewable TabletSYa720c424-517a-461b-8e13-6c37caf8aa3f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50458-675-2050458067520200 TABLET, CHEWABLE in 1 BOTTLE (50458-675-20) 2016-10-200000-00-00NoNoCurrent