FDA.reportPublic FDA data

Ponazuril

Manufacturer
AMERICAN PHARMACEUTICAL INGREDIENTS LLC
Effective date
2014-04-29
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:57

Label at a glance#

ProductPonazuril
Active ingredientPonazuril
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
58597-8452-3Ponazuril10 g in 1 BOTTLEPOWDER101
58597-8452-4Ponazuril25 g in 1 BOTTLEPOWDER251
58597-8452-6Ponazuril100 g in 1 BOTTLEPOWDER1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58597-8452PONAZURIL POWDER [AMERICAN PHARMACEUTICAL INGREDIENTS LLC]13 package rows20140430_cd85ddd1-cf2e-49a0-9fc9-af271b7df36b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PonazurilACTIVE INGREDIENTJPW84AS66U1
PonazurilACTIVE MOIETYJPW84AS66U1

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
58597-845258597-8452-3, 58597-8452-4, 58597-8452-6

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
PonazurilJPW84AS66UACTIB

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

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