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 22 of 93 · 1,850 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexlido-M KitDEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, MARICAINE, POVIDINE IODINEAsclemed USA, Inc.d3fd1d51-7749-4e1e-a8b5-8a151392f66d2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1812079
Physician EZ Use Joint Tunnel and Trigger Kit IILIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINEAsclemed USA, Inc.0d2d52ef-ff21-4b28-b8ae-6a46570f7a742026-01-08Warnings, Adverse reactionsExact identifier
ndc (package): 0409-4713-42
DoubleDex KitDEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINEAsclemed USA, Inc.b7d58d9b-e1fa-4a7f-afca-beb06d0280572026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1812079
Mardex 25 KitDEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.94472ddb-ae1d-4a11-a673-81254d562e6b2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1812079
Burn Relief AloeLIDOCAINE HCLAcutens48c435fe-2670-4b80-bf01-923dc93544222026-01-08WarningsExact identifier
unii: V13007Z41A
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
unii: V13007Z41A
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus Liquescence 3023SPLEEN THYMUS LIQUESCENCEProfessional Complementary Health Formulasabe3c5c4-c5b4-47dd-afe3-b7858c82f7752026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Bladder 7006RET BLADDERProfessional Complementary Health Formulasf1d354e7-3d72-40aa-aaf1-172cb39f07112026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: 451W47IQ8X
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: 451W47IQ8X
Opsin II 6015OPSIN IIProfessional Complementary Health Formulas848d620e-ddd5-4787-a4bd-844be76154322026-01-08WarningsExact identifier
unii: 451W47IQ8X
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
unii: V13007Z41A
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: 451W47IQ8X
Headache Drops 2027HEADACHE DROPSProfessional Complementary Health Formulasa7e345fb-c4aa-4b10-8074-9d8c373041422026-01-08WarningsExact identifier
unii: 451W47IQ8X
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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