FDA.reportPublic FDA data

NDC 76045-109-01 - Dexamethasone Sodium Phosphate

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
76045-109
Requested NDC
76045-109-01
Package NDCs from labels
76045-109-01, 76045-109-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone Sodium Phosphate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-12-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76045-109-01Dexamethasone Sodium Phosphate1 mL in 1 SYRINGE, GLASSINJECTION, EMULSION15
76045-109-10Dexamethasone Sodium Phosphate1 in 1 BLISTER PACKINJECTION, EMULSION15
76045-109-10Dexamethasone Sodium Phosphate24 in 1 CARTONINJECTION, EMULSION245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-109DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, EMULSION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 3 package rows20240223_4dd55929-fe0a-4884-ae0d-6f9435920eb7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76045-109-10ML - Milliliter76045-10996d1c1ab-0fdb-4742-a79b-32fd87d22d0812019-11-12

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 6 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEEugia US LLC29947f67-7868-40af-8ad2-a61f7149b44c2025-11-12Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEugia US LLCce7ad5a4-a9c5-42d6-87cc-ca16556208d22025-11-12Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
AQUACETIC-30CLEANING SOLUTION FOR HEMODIALYSIS MACHINESAqua Medica, S.A. de C.V.040775ab-41bd-cd36-e063-6394a90a08aa2025-11-10WarningsExact identifier
unii: 2968PHW8QP
CITRACID-50DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINEAqua Medica, S.A. de C.V.040713e7-67cd-8eb0-e063-6394a90aa2a92025-11-10WarningsExact identifier
unii: 2968PHW8QP
DMT SUIKDEXAMETHASONE SODIUM PHOSPHATEAdvanced Rx of Tennessee, LLC43045630-8bf8-59ae-e063-6294a90a2ebe2025-11-07Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC.41eb3b4a-3386-ebfa-e063-6394a90a4dba2025-10-24Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEHenry Schein, Inc.d9b935d5-1b4f-4a08-8d40-57f397368fef2025-09-29Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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