FDA.reportPublic FDA data

NDC 57319-520 - GENTAMAX

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57319-520
Package NDCs from labels
57319-520-05, 57319-520-06
Manufacturer
Clipper Distributing Company, LLC.
Effective date
2012-12-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GENTAMAX® 100 (GENTAMICIN SULFATE SOLUTION) 100 mg/mLClipper Distributing Company, LLC.2012-12-06PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57319-520-05GENTAMAX100 mL in 1 VIALSOLUTION1001
57319-520-06GENTAMAX250 mL in 1 VIALSOLUTION2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57319-520GENTAMAX (GENTAMICIN INTRA-UTERINE) SOLUTION [CLIPPER DISTRIBUTING COMPANY, LLC.]12 package rows20121207_4940fa85-0201-4d71-9ff9-5ee3ac725036.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMAX (GENTAMICIN INTRA-UTERINE) SOLUTION [CLIPPER DISTRIBUTING COMPANY, LLC.]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMAX (GENTAMICIN INTRA-UTERINE) SOLUTION [CLIPPER DISTRIBUTING COMPANY, LLC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gentamicin sulfateGENTAMICIN SULFATEDIRECT RX51a411a0-2671-4c1c-bf25-e29b32efed0c2024-01-10Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATESandoz Inca213fb9c-08ea-4f30-a6c9-93c7a9ba52802024-01-02Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICINFresenius Kabi USA, LLC8bdeef7f-ad8e-46e0-a872-e945eae51d682023-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.16474069-510b-0754-9d78-9bc0354f65492023-11-23Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.9e550dc9-509e-da05-8a97-ecbd0f5dd6332023-11-22Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICIN SULFATEMedical Purchasing Solutions, LLC09cf88af-59da-f147-e063-6294a90aac992023-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLC0cce2238-28d3-4280-b520-ffc3067a2ffa2023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICINFresenius Kabi USA, LLCbe5b414e-d598-4721-80ee-5836156ad2102023-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLCa73a5453-c091-43fd-aae2-d992152363b12023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICINHikma Pharmaceuticals USA Inc.51fffac8-fb6e-4f7f-b2de-440252781a422023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEA-S Medication Solutions76fabcd6-4da3-49e3-85a1-ca4fac55a2072023-05-08Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEMedical Purchasing Solutions, LLCa8b15217-cccb-2260-e053-2995a90a709d2023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltd4cfbe37e-11d6-46fc-b287-0561387b17b72023-01-31Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEAsclemed USA, Inc.b59e49e0-640b-43c3-ad07-711d1bb154e92022-07-19Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP3a6677a6-def5-443e-82bc-c185d41f03b72022-06-01Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEAsclemed USA, Inc.a54e5c95-609d-4d66-9573-5d1ac78fa58f2022-03-04Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LPcf4386ba-c62a-4ee8-ab59-1bb2e737a5da2021-05-01Adverse reactionsExact identifier
unii: 8X7386QRLV
GentakGENTAMICIN SULFATEProficient Rx LPaebfe247-cdf7-4acb-97b3-6d4341d7c8152019-11-01Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP2098faaa-7f60-4640-8c37-19456ebba6532019-11-01Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV

Reported adverse events (FAERS/openFDA)#

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