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 16 of 17 · 323 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 1Q73Q2JULR
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.b2ce414a-3b1f-4533-bb3a-18594529dead2020-11-25Warnings, Adverse reactionsExact identifier
rxcui: 1812194
unii: AI9376Y64P
GUNA FLAM RELIEFACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
unii: 2968PHW8QP
DMT SUIKDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.a7b7884a-6bd4-4d06-8f14-0759450c07242020-06-17Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMylan Institutional LLC836f8017-d023-410b-8515-ec776e73ca592019-11-04Warnings, Adverse reactionsExact identifier
rxcui: 1116927
rxcui: 1812194
rxcui: 309696
unii: AI9376Y64P
GUNA-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
unii: 2968PHW8QP
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR
Ivy-Dry SuperBENZYL ALCOHOL, CAMPHOR, MENTHOLIvy-Dry, Inc.4792a667-2378-4b3d-968d-9efb1866792f2017-12-27WarningsExact identifier
unii: LKG8494WBH
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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