NDC 13985-566 - GenOne

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
13985-566
Package NDCs from labels
13985-566-60, 13985-566-12, 13985-566-24
Manufacturer
MWI | FIRST PRIORITY INCORPORATED
Effective date
2023-09-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GenOne - MWI | FIRST PRIORITY INCORPORATEDMWI | FIRST PRIORITY INCORPORATED2023-09-26PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-566-12GenOne120 mL in 1 BOTTLE, SPRAYSPRAY1207
13985-566-12GenOne12 in 1 CASESPRAY127
13985-566-24GenOne240 mL in 1 BOTTLE, SPRAYSPRAY2407
13985-566-24GenOne12 in 1 CASESPRAY127
13985-566-60GenOne60 mL in 1 BOTTLE, SPRAYSPRAY607
13985-566-60GenOne12 in 1 CASESPRAY127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-566GENONE (GENTAMICIN SULFATE) SPRAY [MWI]76 package rows20230927_83e23b7f-9007-487f-b519-65fb4707fbbc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE VALERATEACTIVE INGREDIENT9IFA5XM7R2GENONE (GENTAMICIN SULFATE) SPRAY [MWI]5
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENONE (GENTAMICIN SULFATE) SPRAY [MWI]5
BETAMETHASONEACTIVE MOIETY9842X06Q6MGENONE (GENTAMICIN SULFATE) SPRAY [MWI]5
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENONE (GENTAMICIN SULFATE) SPRAY [MWI]5

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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Betamethasone ValerateBETAMETHASONE VALERATE FOAMXiromed, LLC.dee8f6d1-b0ba-3c56-f08d-eb6283b0b2502023-05-08Warnings, Adverse reactionsExact identifier
unii: 9IFA5XM7R2
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
Betamethasone ValerateBETAMETHASONE VALERATEProficient Rx LP036706f1-0a24-4765-9a62-820ad64934be2022-06-01Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Betamethasone ValerateBETAMETHASONE VALERATECosette Pharmaceuticals, Inc.784476d2-5e5c-fdba-a677-8973a777b5ef2022-05-05Adverse reactionsExact identifier
unii: 9IFA5XM7R2
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
Betamethasone ValerateBETAMETHASONE VALERATEProficient Rx LP2a64b65b-8a49-45ea-9464-2269751c075c2021-04-01Adverse reactionsExact identifier
unii: 9IFA5XM7R2
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.