FDA.reportPublic FDA data

Fenbendazole

Manufacturer
AMERICAN PHARMACEUTICAL INGREDIENTS LLC
Effective date
2014-04-25
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:55

Label at a glance#

ProductFenbendazole
Active ingredientFenbendazole
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58597-8227-6Fenbendazole100 g in 1 BOTTLEPOWDER1001
58597-8227-7Fenbendazole500 g in 1 BOTTLEPOWDER5001
58597-8227-8Fenbendazole1000 g in 1 BOTTLEPOWDER10001
58597-8227-9Fenbendazole5000 g in 1 BOTTLEPOWDER50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58597-8227FENBENDAZOLE POWDER [AMERICAN PHARMACEUTICAL INGREDIENTS LLC]14 package rows20140425_44afa8a7-c9bf-4733-917a-182e184e4c56.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FenbendazoleACTIVE INGREDIENT621BVT9M361
FenbendazoleACTIVE MOIETY621BVT9M361

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58597-822758597-8227-6, 58597-8227-7, 58597-8227-8, 58597-8227-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
Fenbendazole621BVT9M36ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.