FDA.reportPublic FDA data

NDC 63323-108-00 - Magnesium Sulfate in 5% Dextrose

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
63323-108
Requested NDC
63323-108-00
Package NDCs from labels
63323-108-00, 63323-108-01, 63323-108-02, 63323-108-26
Manufacturer
Fresenius Kabi USA, LLC | HP Halden Pharma AS
Effective date
2024-04-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Magnesium Sulfate in 5% Dextrose - Fresenius Kabi USA, LLC | HP Halden Pharma ASFresenius Kabi USA, LLC | HP Halden Pharma AS2024-04-24HUMAN PRESCRIPTION DRUG LABEL
Magnesium Sulfate in 5% Dextrose - Fresenius Kabi USA, LLC | HP Halden Pharma ASFresenius Kabi USA, LLC | HP Halden Pharma AS2024-04-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-108-00Magnesium Sulfate in 5% Dextrose100 mL in 1 BAGINJECTION, SOLUTION1008
63323-108-01Magnesium Sulfate in 5% Dextrose24 in 1 CASEINJECTION, SOLUTION248
63323-108-02Magnesium Sulfate in 5% Dextrose100 mL in 1 BAGINJECTION, SOLUTION1004
63323-108-26Magnesium Sulfate in 5% Dextrose24 in 1 CASEINJECTION, SOLUTION244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-108MAGNESIUM SULFATE IN 5% DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 2 package rows20240515_cea3f48b-375a-415a-a341-435c09719f7c.zip
63323-108MAGNESIUM SULFATE IN 5% DEXTROSE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20240515_fdffb339-89d1-4495-97b7-d9422d68b3d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-108-00ML - Milliliter63323-108369059df-57c4-4452-aa3b-bf6f1d1e9c2612020-07-13
63323-108-01ML - Milliliter63323-108ad77997b-305c-4f32-b81b-46965bdf8db512016-07-19
63323-108-26ML - Milliliter63323-1084d78bb43-25ec-4412-b9a0-f8719342ee4b12017-04-05

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 1 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
PollutoxACETONE, ARSENICUM ALBUM, BENZINUM, BERBERIS VULGARIS, CADMIUM SULPHURATUM, CARBON DIOXIDE, CARBONEUM SULPHURATUM, CHLORINUM, HYDROFLUORICUM ACIDUM, MELATONIN, MERCURIUS SOLUBILIS, NITROGENUM OXYGENATUM, NUX VOMICA, OZONE, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, SULPHURICUM ACIDUM, TOLUENE, URANIUM NITRICUMDeseret Biologicals, Inc.741fdddf-75af-45a2-9875-ee3b08b0decf2026-09-08WarningsExact identifier
unii: O40UQP6WCF
Epsom SaltMAGNESIUM SULFATETarget Corporation87f98e6c-a3a1-4ca5-bd56-977e38f489142026-09-04Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLC5a0f9db9-b8be-c923-e063-6394a90a7dd72026-08-27Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATECardinal Health, 110 dba Leaderd27dc1cc-5e17-40d3-84fe-c1792552cfd52026-08-25Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium Sulfate in WaterMAGNESIUM SULFATEWG Critical Care, LLC752f55bb-c4ca-4545-94b3-3deea66888d42026-08-25Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.22ca78b4-f5a3-4144-cf89-5f633acf1e6d2026-08-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEREMEDYREPACK INC.8c6b8b3d-9c04-4ed7-86b8-89065b6bf50d2026-08-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium Sulfate in DextroseMAGNESIUM SULFATE IN DEXTROSEHospira, Inc.03ebeabb-8386-4af4-3086-bdf3c3fc4a5a2026-08-24Warnings, Adverse reactionsExact identifier
rxcui: 829757
unii: SK47B8698T
Epsom SaltEPSOM SALTAmerisourceBergen (Good Neighbor Pharmacy) 46122d22fb02f-09c4-476a-b6d6-d3a2fd30049d2026-08-18WarningsExact identifier
unii: SK47B8698T
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Epsom SaltMAGNESIUM SULFATESafeway Inc0b757160-f9eb-4413-9b43-97544c49c72f2026-08-10Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, OZONE, URANIUM NITRICUMDeseret Biologicals, Inc.e7000300-69ec-47db-8059-3f873d64f1772026-07-31WarningsExact identifier
unii: O40UQP6WCF
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: LX22YL083G
DextroseDEXTROSE MONOHYDRATEHospira, Inc.4ed365da-4e62-4329-c1b9-c197ab4fb6e12026-07-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Infant DextroseDEXTROSEHenry Schein, Inc.ce71d929-d11e-444c-bd45-e025d51720572026-07-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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