FDA.reportPublic FDA data

NDC 0641-6146-01 - 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
0641-6146
Requested NDC
0641-6146-01
Package NDCs from labels
0641-6146-01, 0641-6146-10, 0641-6146-25
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 onlyHikma Pharmaceuticals USA Inc.2026-01-22HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate Injection, USP Rx onlyHenry Schein, Inc.2025-09-29HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate Injection, USP Rx onlyREMEDYREPACK INC.2024-10-04HUMAN PRESCRIPTION DRUG LABEL
DEXAMETHASONE SODIUM PHOSPHATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-05-28HUMAN PRESCRIPTION DRUG LABEL
DEXAMETHASONE SODIUM PHOSPHATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-30HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6146-01Dexamethasone Sodium Phosphate5 mL in 1 VIALINJECTION521
0641-6146-10Dexamethasone Sodium Phosphate10 in 1 CARTONINJECTION1021
0641-6146-25Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION2521

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6146DEXAMETHASONE SODIUM PHOSPHATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]20Current NDC, Legacy NDC, 3 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
0641-6146-01ML - Milliliter0641-6146729ad5b5-3d58-4f75-801a-04c2d6bded6412017-03-06
0641-6146-10ML - Milliliter0641-6146d128e26c-4c17-4e5a-a8c9-6294d25f1f0a12024-01-04
0641-6146-25ML - Milliliter0641-61465774f795-5bd6-4205-bb98-b67d1b93879e12017-03-06

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 10 of 17 · 321 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAdvanced Rx Pharmacy of Tennessee, LLCf4d6c7c8-7a77-6a46-e053-2995a90a44112024-12-31Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECivica, Inc.d54a27f2-2af8-4f86-a7fd-453f6b1a99972024-12-26Warnings, Adverse reactionsExact identifier
application number: ANDA087702
application number: ANDA084282
rxcui: 1116927
rxcui: 309696
unii: AI9376Y64P
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESomerset Therapeutics, LLC799028e2-c0e4-494f-89ff-1b786babc34a2024-12-19Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
unii: LKG8494WBH
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharmace42122f-8087-471f-b0a3-5524bdbd45262024-11-19Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Sal de Uvas PicotCITRIC ACID MONOHYDRATE AND SODIUM BICARBONATERB Health Mexico, S.A. de C.V.151b9bc9-1a6e-4401-ae58-4b4210ab45052024-11-15WarningsExact identifier
unii: 2968PHW8QP
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEPharmaceutical Associates, Inc.63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd52024-11-13Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
AddiclenzBOLDO, CARDUUS MARIANUS, 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.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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