FDA.reportPublic FDA data

Phenylbutazone

Manufacturer
AMERICAN PHARMACEUTICAL INGREDIENTS LLC
Effective date
2014-04-28
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:56

Label at a glance#

ProductPhenylbutazone
Active ingredientPhenylbutazone
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
58597-8437-9Phenylbutazone5000 g in 1 BOTTLEPOWDER50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58597-8437PHENYLBUTAZONE POWDER [AMERICAN PHARMACEUTICAL INGREDIENTS LLC]11 package rows20140429_d2072453-7fb7-46cc-b4f5-d87e346630ff.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PhenylbutazoneACTIVE INGREDIENTGN5P7K3T8S1
PhenylbutazoneACTIVE MOIETYGN5P7K3T8S1

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
58597-843758597-8437-9

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
PhenylbutazoneGN5P7K3T8SACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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