FDA.reportPublic FDA data

NDC 0641-0367-21 - 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
0641-0367
Requested NDC
0641-0367-21
Package NDCs from labels
0641-0367-21, 0641-0367-25
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-04-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone Sodium Phosphate - Cardinal Health 107, LLCCardinal Health 107, LLC2026-04-21HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate Injection, USP Rx onlyREMEDYREPACK INC.2026-03-16HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate - A-S Medication SolutionsA-S Medication Solutions2026-02-02HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate Injection, USP Rx onlyHikma Pharmaceuticals USA Inc.2026-01-22HUMAN PRESCRIPTION DRUG LABEL
DEXAMETHASONE SODIUM PHOSPHATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-04HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-23HUMAN PRESCRIPTION DRUG LABEL
ReadySharp Anesthetics plus Dexamethasone - Terrain PharmaceuticalsTerrain Pharmaceuticals2017-12-19HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-0367-21Dexamethasone Sodium Phosphate1 mL in 1 VIALINJECTION121
0641-0367-25Dexamethasone Sodium Phosphate25 in 1 CARTONINJECTION2521

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-0367DEXAMETHASONE 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
0641-0367-21ML - Milliliter0641-03670ac648a0-35ec-434c-b33d-1645e8a8cc7412012-07-24
0641-0367-25ML - Milliliter0641-0367b7f2dd89-0a90-48e6-ad12-aef4345ecf3812012-07-24

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
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION [CARDINAL HEALTH]3
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION [CARDINAL HEALTH]3
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGADEXAMETHASONE SODIUM PHOSPHATE INJECTION [CARDINAL HEALTH]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEXAMETHASONE SODIUM PHOSPHATE INJECTION [CARDINAL HEALTH]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION [CARDINAL HEALTH]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION [CARDINAL HEALTH]3
SODIUM SULFATE ANHYDROUSINACTIVE INGREDIENT36KCS0R750DEXAMETHASONE SODIUM PHOSPHATE INJECTION [CARDINAL HEALTH]3
waterINACTIVE INGREDIENT059QF0KO0RDEXAMETHASONE SODIUM PHOSPHATE INJECTION [CARDINAL HEALTH]3

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 5 of 98 · 1,960 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspercreme Professional CreamLIDOCAINE HCL 4%Chattem, Inc.ef297864-5917-4645-8ec7-f2bc49e037e82026-07-29WarningsExact identifier
unii: V13007Z41A
Xylocaine MPFLIDOCAINE HYDROCHLORIDESportpharm LLC50aa6133-0776-4714-9821-fe8581f635ca2026-07-28Warnings, Adverse reactionsExact identifier
rxcui: 1737757
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dental9419ac39-9b26-4cca-a2d6-167205fede242026-07-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dental6506755f-c9f7-4286-9ba7-ac5d5745f5e42026-07-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLC27e8fdfb-e923-4f99-aff7-8b9e502281512026-07-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLCe5ed4c2a-e320-48cf-a2fd-61d48481c6242026-07-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dentalf074c0dc-7c3f-46fd-a480-b8337a19fe5c2026-07-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
unii: V13007Z41A
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsExact identifier
unii: V13007Z41A
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
unii: V13007Z41A
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC573a7298-b02e-230c-e063-6294a90a269c2026-07-22Warnings, Adverse reactionsExact identifier
rxcui: 1010671
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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