FDA.reportPublic FDA data

X

Manufacturer
AX Pharmaceutical Corp
Effective date
2016-09-10
Label type
BULK INGREDIENT
Version
4
Source
full-release
Hydrated at
2026-06-01 02:48:20

Label at a glance#

ProductX
Active ingredientDICLAZURIL
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
62157-076-01X500 g in 1 BOTTLEPOWDER5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62157-076X (DICLAZURIL) POWDER [AX PHARMACEUTICAL CORP]41 package rows20160910_edf742d4-1f07-4fd9-9335-9217b77d3445.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DICLAZURILACTIVE INGREDIENTK110K1B1VE1
DICLAZURILACTIVE MOIETYK110K1B1VE1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62157-07662157-076-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICLAZURILK110K1B1VEACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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