FDA.reportPublic FDA data

NDC 0641-6145-01 - 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
0641-6145
Requested NDC
0641-6145-01
Package NDCs from labels
0641-6145-01, 0641-6145-25
Manufacturer
ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2026-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DEXAMETHASONE - ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEMASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM2026-08-07HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate Injection, USP Rx onlyREMEDYREPACK INC.2026-04-15HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate Injection, USP Rx onlyHikma Pharmaceuticals USA Inc.2026-01-22HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-15HUMAN PRESCRIPTION DRUG LABEL
SODIUM SULFITE - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2023-04-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6145-01Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION121
0641-6145-25Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION2521

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6145DEXAMETHASONE SODIUM PHOSPHATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]20Current NDC, Legacy NDC, 2 package rows20240606_0277cc0a-2fd4-4605-a310-b613be84ee26.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6145-01ML - Milliliter0641-614524b67700-181d-49f7-a823-888fc80b92e912017-03-06
0641-6145-25ML - Milliliter0641-61457721d930-5465-4c7c-88b1-13be9ed1bd2f12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGADEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8
WATERINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]8

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 17 · 323 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC8effed8e-9a75-eb3e-e053-2a95a90a965b2023-05-15Warnings, Adverse reactionsExact identifier
application number: ANDA084282
rxcui: 1116927
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC8969803e-2e45-1f28-e053-2995a90a05a72023-05-15Warnings, Adverse reactionsExact identifier
application number: ANDA084282
ndc (package): 71872-7164-1
ndc (product): 71872-7164
rxcui: 1116927
spl id: fbbf4fd1-a825-fc54-e053-6294a90af912
spl set id: 8969803e-2e45-1f28-e053-2995a90a05a7
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
rxcui: 309696
unii: AI9376Y64P
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC9f69846e-5897-c301-e053-2a95a90a44f12023-05-03Warnings, Adverse reactionsExact identifier
rxcui: 309696
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
application number: ANDA084282
ndc (package): 76420-555-01
ndc (product): 76420-555
rxcui: 1812194
spl id: f87f3d2b-033d-ea7a-e053-6394a90ac766
spl set id: 2d96d5e8-00bf-406b-b345-f1c31865fe94
unii: AI9376Y64P
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst94cb045b-5801-db32-e053-2a95a90a93ef2022-12-10Warnings, Adverse reactionsExact identifier
rxcui: 1116927
unii: AI9376Y64P
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.ca762fbf-6bf5-4b39-8f40-3fb5f1f777782022-10-12Warnings, Adverse reactionsExact identifier
rxcui: 1812194
unii: AI9376Y64P
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEBausch & Lomb Incorporated6bdcefbe-51e3-4ca4-afda-5aeca7b6fa732022-08-31Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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