FDA.reportPublic FDA data

NDC 68083-474-01 - 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
68083-474
Requested NDC
68083-474-01
Package NDCs from labels
68083-474-01, 68083-474-25
Manufacturer
Gland Pharma Limited
Effective date
2024-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone Sodium Phosphate - Gland Pharma LimitedGland Pharma Limited2024-06-26Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-474-01Dexamethasone Sodium Phosphate5 mL in 1 VIAL, MULTI-DOSEINJECTION57
68083-474-25Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-474DEXAMETHASONE SODIUM PHOSPHATE INJECTION [GLAND PHARMA LIMITED]7Current NDC, Legacy NDC, 2 package rows20240705_c9d9ab76-6bc6-433d-aad7-8d49064ed745.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 15 of 18 · 350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC69344707-904d-7ba2-e053-2a91aa0a31f42023-05-23Warnings, Adverse reactionsExact identifier
rxcui: 1812079
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC69485218-9330-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
rxcui: 1116927
unii: AI9376Y64P
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC86091483-2053-5da8-e053-2a91aa0a6f452023-05-16Warnings, Adverse reactionsExact identifier
rxcui: 1116927
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC81a28bdb-b186-8047-e053-2a91aa0a4e0a2023-05-16Warnings, Adverse reactionsExact identifier
rxcui: 1812194
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC81a0503c-39fe-1c67-e053-2a91aa0a5b8f2023-05-16Warnings, Adverse reactionsExact identifier
rxcui: 1116927
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC8effed8e-9a75-eb3e-e053-2a95a90a965b2023-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1116927
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC8969803e-2e45-1f28-e053-2995a90a05a72023-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1116927
unii: AI9376Y64P
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLCbbf0f0ee-1891-4f3d-e053-2a95a90a5e182023-05-04Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC9f69846e-5897-c301-e053-2a95a90a44f12023-05-03Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC667323ea-5a5e-3465-e053-2a91aa0a16672023-04-26Warnings, Adverse reactionsExact identifier
rxcui: 1116927
unii: AI9376Y64P
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.2d96d5e8-00bf-406b-b345-f1c31865fe942023-04-04Warnings, Adverse reactionsExact identifier
rxcui: 1812194
unii: AI9376Y64P
Emetrol Chewables Mixed BerrySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation4965fab0-828d-4f1d-8d43-a636e0a8c1ea2023-03-23WarningsExact identifier
unii: B22547B95K
Emetrol Chewables OrangeSODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporatione9072f9d-d74c-4e43-bcfe-ee005577df352023-03-23WarningsExact identifier
unii: B22547B95K
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
triCitrasolTRISODIUM CITRATE DIHYDRATECitra Labs LLC64e7652c-1437-43bd-8ea2-3cafab447b8c2023-02-14Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Anticoagulant Citrate Dextrose AANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATECitra Labs LLC5bcd261e-ebba-4ecb-af22-e5aaeb04499b2023-02-14Warnings, Adverse reactionsExact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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