FDA.reportPublic FDA data

ENROFLOXACIN

Manufacturer
Professional Compounding Centers of America dba PCCA
Effective date
2022-11-17
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
2
Source
full-release
Hydrated at
2026-06-01 02:51:10

Label at a glance#

ProductENROFLOXACIN
Active ingredientENROFLOXACIN
Label structure1 sections

Label contents#

Full prescribing information#

ENROFLOXACIN USPFOR VETERINARY USE ONLY *PROTECT FROM LIGHT*For Prescription Compounding/Rx OnlyPART: 30-4815 GMCAS: 93106-60-6DANGER: HARMFUL SUBSTANCE. IRRITATING SUBSTANCE. MAY CAUSE EYE, SKIN OR RESPIRATORY IRRITATION. POSSIBLE HYPERSENSITIZATION. AVOID...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENROFLOXACIN USPimage descriptionimage description
FOR VETERINARY USE ONLY *PROTECT FROM LIGHT*
For Prescription Compounding/Rx Only
PART: 30-4815 GM
CAS: 93106-60-6
DANGER: HARMFUL SUBSTANCE. IRRITATING SUBSTANCE. MAY CAUSE EYE, SKIN OR RESPIRATORY IRRITATION. POSSIBLE HYPERSENSITIZATION. AVOID RAISING AND BREATHING DUST USE ADEQUATE VENTILATION. AVOID ALKALIES. EMITS TOXIC FUMES UNDER FIRE CONDITIONS. WASH THOROUGHLY AFTER HANDLING. STORE IN TIGHTLY CLOSED CONTAINER. PRESERVE IN WELL-CLOSED,LIGHT RESISTANT CONTAINER. STORE AT ROOM TEMPERATURE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51927-0258-0ENROFLOXACIN1 kg in 1 CONTAINERPOWDER12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51927-0258ENROFLOXACIN POWDER [PROFESSIONAL COMPOUNDING CENTERS OF AMERICA DBA PCCA]21 package rows20241006_01e46f93-ef45-427d-8341-6cefdbb9fae1.zip

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
51927-025851927-0258-0
51943-001

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
ENROFLOXACIN3DX3XEK1BNACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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