FDA.reportPublic FDA data

PONAZURIL

Manufacturer
Compound One Pharmaceuticals Inc.
Effective date
2013-10-16
Label type
BULK INGREDIENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:47:47

Label at a glance#

ProductPONAZURIL
Active ingredientPONAZURIL
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58645-001-01PONAZURIL55 g in 1 DRUMPOWDER553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58645-001PONAZURIL POWDER [COMPOUND ONE PHARMACEUTICALS INC.]31 package rows20131016_b4e3ae2c-a99e-49ef-b005-a23acf471e7d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PONAZURILACTIVE INGREDIENTJPW84AS66U3
PONAZURILACTIVE MOIETYJPW84AS66U3

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
58645-00158645-001-01

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

Reported adverse events (FAERS/openFDA)#

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