FDA.reportPublic FDA data

NDC 55150-433 - DEXRAZOXANE

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
55150-433
Package NDCs from labels
55150-433-02, 55150-433-01
Manufacturer
Eugia US LLC | GLAND PHARMA LIMITED
Effective date
2026-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DEXRAZOXANE - Eugia US LLC | GLAND PHARMA LIMITEDEugia US LLC | GLAND PHARMA LIMITED2026-08-10Human Prescription Drug Label
DEXRAZOXANE - Eugia US LLC | GLAND PHARMA LIMITEDEugia US LLC | GLAND PHARMA LIMITED2024-11-02Human Prescription Drug Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-433DEXRAZOXANE KIT [EUGIA US LLC]3Unmatched20241109_be9ac1e9-21a9-439a-9029-9f03513220ea.zip
55150-433DEXRAZOXANE KIT [AUROMEDICS PHARMA LLC]1Unmatched20220721_cb72203a-0b09-42d5-bf51-7f479feb3adb.zip

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 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: TU7HW0W0QT
Lactated RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDEBaxter Healthcare Companydad7735c-709b-40ea-ab7a-15577e24a9662025-10-29Warnings, Adverse reactionsExact identifier
unii: TU7HW0W0QT
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.b96eb740-749a-4d3a-ae63-b8e3947cad302025-10-23Warnings, Adverse reactionsExact identifier
unii: TU7HW0W0QT
DexrazoxaneDEXRAZOXANE FOR INJECTIONAlmaject, Inc.9cbd2987-10bb-eceb-153d-ee7be1ed0c842025-08-01Warnings, Adverse reactionsExact identifier
rxcui: 1736590
unii: 5346058Q7S
DexrazoxaneDEXRAZOXANE FOR INJECTIONAlmaject, Inc.e9550d22-6069-a6de-9968-6a18c9e0448f2025-08-01Warnings, Adverse reactionsExact identifier
rxcui: 1736590
unii: 5346058Q7S
DexrazoxaneDEXRAZOXANENovadoz Pharmaceuticals LLCa7c01089-85f5-40aa-b679-f53a425b4d682025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 1736590
rxcui: 1736585
unii: 5346058Q7S
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
unii: TU7HW0W0QT
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
unii: TU7HW0W0QT
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCd5b85158-b0d6-4855-9d07-8d1b3ad9ab712025-06-30Warnings, Adverse reactionsExact identifier
unii: TU7HW0W0QT
DexrazoxaneDEXRAZOXANE FOR INJECTIONGland Pharma Limitedc9c625fc-8852-4ed4-bcf2-63f46a7067822025-06-23Warnings, Adverse reactionsExact identifier
rxcui: 1736590
rxcui: 1736585
unii: 5346058Q7S
DexrazoxaneDEXRAZOXANE FOR INJECTIONFosun Pharma USA Inc.c1d98fbe-5fd9-4518-b1a5-fac92e32928f2025-06-17Warnings, Adverse reactionsExact identifier
rxcui: 1736590
rxcui: 1736585
unii: 5346058Q7S
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC67bee807-7ba8-4e92-81f2-c888118d277e2025-05-09Exact identifier
unii: TU7HW0W0QT
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0fb30b7e-8e1b-49c7-afac-2d5c01b9ff452025-05-09Exact identifier
unii: TU7HW0W0QT
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb0f2c9a2-d9d4-4907-a324-e7a26d489f442025-05-09Exact identifier
unii: TU7HW0W0QT
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCa829d4eb-3ec5-453c-b270-793969af15b32025-05-09Exact identifier
unii: TU7HW0W0QT
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLC5bf31b49-24c8-4021-98da-33a151f2fcbe2025-05-08Exact identifier
unii: TU7HW0W0QT
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC50fc30a0-0eca-452e-825e-08c2647ccfc12025-05-08Exact identifier
unii: TU7HW0W0QT
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCe18bacfe-af60-49dc-bd30-cb3c29fa16db2025-05-07Exact identifier
unii: TU7HW0W0QT
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLC2b327b13-a0e9-4b2c-9875-4470998e2e302025-05-07Exact identifier
unii: TU7HW0W0QT
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb2b780d3-26ac-4e7c-a0f2-78991bee32a82025-05-07Exact identifier
unii: TU7HW0W0QT

Reported adverse events (FAERS/openFDA)#

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