FDA.reportPublic FDA data

NDC 63323-516-01 - 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
63323-516
Requested NDC
63323-516-01
Package NDCs from labels
63323-516-01, 63323-516-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2026-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone Sodium Phosphate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-06-30HUMAN PRESCRIPTION DRUG LABEL
DEXAMETHASONE SODIUM PHOSPHATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2026-03-23HUMAN PRESCRIPTION DRUG LABEL
Dexamethasone Sodium Phosphate - A-S Medication SolutionsA-S Medication Solutions2021-04-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-516-01Dexamethasone Sodium Phosphate10 mL in 1 VIALINJECTION, SOLUTION1011
63323-516-10Dexamethasone Sodium Phosphate10 in 1 TRAYINJECTION, SOLUTION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-516DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]9Current NDC, Legacy NDC, 2 package rows20240725_cca2c160-9188-48e8-9505-49a52388dcb7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-516-01ML - Milliliter63323-5163730edd9-e959-4a29-8817-9a8f025b511a12024-11-05
63323-516-10ML - Milliliter63323-516d7f3c390-399d-47c9-94c4-a130752907ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONE SODIUM PHOSPHATEACTIVE INGREDIENTAI9376Y64PDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

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 17 · 330 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCce25183b-cd67-4997-8de9-df59b750883b2025-12-24Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEProPharma Distribution384206f5-75ed-9bd2-e063-6294a90a50382025-12-18Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEProPharma Distribution42c879cc-38dc-c9bc-e063-6294a90a204d2025-12-18Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC4dd55929-fe0a-4884-ae0d-6f9435920eb72025-12-17Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC88d25d19-acff-477b-86c8-9797782045b82025-12-11Warnings, Adverse reactionsExact identifier
unii: AI9376Y64P
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 2968PHW8QP
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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