FDA.reportPublic FDA data

NDC 63323-107-01 - magnesium sulfate

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
63323-107
Requested NDC
63323-107-01
Package NDCs from labels
63323-107-01, 63323-107-05
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 - 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
63323-107-01magnesium sulfate50 mL in 1 BAGINJECTION, SOLUTION506
63323-107-05magnesium sulfate24 in 1 CASEINJECTION, SOLUTION246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-107MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20240427_fef9e18c-5210-4090-b564-4950ebe461c0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-107-01ML - Milliliter63323-1075ab675e1-fdf3-4e59-b124-ea99645fde2612020-08-06
63323-107-05ML - Milliliter63323-1070db0dd93-1d1d-4f5c-8ba6-60e944bc733b12016-07-19

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 9 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAGNESIUM SULFATEMAGNESIUM SULFATE HEPTAHYDRATEGland Pharma Limiteda9e706ac-9c5f-4b14-b277-53dee195ffc62020-07-14Warnings, Adverse reactionsExact identifier
rxcui: 1658259
rxcui: 1658262
unii: SK47B8698T
GastrozenCOFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM ACNatural Creations, Inc98dd756f-6774-47c3-bdfb-deff82fb801d2018-12-21WarningsExact identifier
unii: O40UQP6WCF
Injure GelARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERF, SYMPHYTUM OFF, BELLIS PER, LEDUM PALUSTRE, SULPHURICUM AC, CALC FLUOR, FERRUM PHOS, RHUS TOX, NAT SULPHURICUMNatural Creations, Inc8893c906-0dab-44ef-956b-b5427d4dbf7f2018-12-21WarningsExact identifier
unii: O40UQP6WCF
Hangover ReliefASAFETIDA,CAPSICUM,POTASSIUM DICHROMATE,COLA NUT,LACHESIS MUTA VENOM,STRYCHNOS NUX-VOMICA SEED,RANUNCULUS BULBOSUS,SULFURIC ACID,ZINC.Homeocare Laboratories93b4a184-572c-48ef-9fc0-8e357a1e0d1b2018-12-18WarningsExact identifier
unii: O40UQP6WCF
Trauma plus GelCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUMEnergique, Inc.6da04ff9-4088-427c-9757-36092c8f75852018-02-08WarningsExact identifier
unii: O40UQP6WCF
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: SK47B8698T

Reported adverse events (FAERS/openFDA)#

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