FDA.reportPublic FDA data

NDC 54925-028-06 - Betagen

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
54925-028
Requested NDC
54925-028-06
Package NDCs from labels
54925-028-06, 54925-028-12, 54925-028-24
Manufacturer
Med-Pharmex, Inc
Effective date
2023-04-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Betagen - Med-Pharmex, IncMed-Pharmex, Inc2023-04-17PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54925-028BETAGEN (GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE) SPRAY [MED-PHARMEX, INC]4Unmatched20230418_c98854e7-55a7-4edc-9aa5-e67626008683.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE VALERATEACTIVE INGREDIENT9IFA5XM7R2BETAGEN (GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE) SPRAY [MED-PHARMEX, INC]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVBETAGEN (GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE) SPRAY [MED-PHARMEX, INC]1
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAGEN (GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE) SPRAY [MED-PHARMEX, INC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGBETAGEN (GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE) SPRAY [MED-PHARMEX, INC]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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GentamicinGENTAMICINFresenius Kabi USA, LLC63413469-c676-48a3-a945-7d2489b535ef2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLC84f5c763-1cd3-4d85-9afb-934db8666fbf2024-10-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Betamethasone valerateBETAMETHASONE VALERATEAlembic Pharmaceuticals Inc.3b6fa573-de04-4626-a39a-dca39def6df22024-08-23Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals, Inc.4add8f7b-48f0-6b6a-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEBausch & Lomb Incorporated41d01350-5c4b-42fc-be5f-986ceec02bd32024-07-22Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Betamethasone ValerateBETAMETHASONE VALERATENuCare Pharmaceuticals,Inc.a2154b33-0f61-49af-e053-2995a90a18102024-06-20Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.82595309-304e-a221-e053-2991aa0ac0a92024-06-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GENTAMICIN SULFATEGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.85424b40-5c2d-421d-e053-2991aa0a77712024-06-14Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
BETAMETHASONE VALERATEBETAMETHASONE VALERATENuCare Pharmaceuticals,Inc.64badc1a-8922-c6e3-e053-2991aa0a8b1c2024-06-06Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Betamethasone ValerateBETAMETHASONE VALERATEPadagis Israel Pharmaceuticals Ltddc5dfd3e-7762-40c8-880e-c7db80d877492024-03-31Warnings, Adverse reactionsExact identifier
unii: 9IFA5XM7R2
GENTAMICINGENTAMICINHF Acquisition Co LLC, DBA HealthFirstc1ff0cdc-ac5d-30ca-e053-2a95a90a50662024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GENTAMICIN SULFATEGENTAMICIN SULFATEHF Acquisition Co LLC, DBA HealthFirste9fbe619-2afe-f1d7-e053-2a95a90aab292024-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltda9486ae1-350b-41c5-ae0c-a4d692bb2dfd2024-01-15Adverse reactionsExact identifier
unii: 8X7386QRLV
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
Betamethasone ValerateBETAMETHASONE VALERATEA-S Medication Solutionsf8711d17-de6a-45e3-8027-b650308207ed2023-12-15Adverse reactionsExact identifier
unii: 9IFA5XM7R2
Betamethasone ValerateBETAMETHASONE VALERATEA-S Medication Solutionsd265d143-343f-41ec-9cb4-18d83edb772b2023-12-12Adverse reactionsExact identifier
unii: 9IFA5XM7R2
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

Reported adverse events (FAERS/openFDA)#

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