FDA.reportPublic FDA data

NDC 63323-642-01 - 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
63323-642
Requested NDC
63323-642-01
Package NDCs from labels
63323-642-01, 63323-642-20, 63323-642-02, 63323-642-50
Manufacturer
Henry Schein, Inc.
Effective date
2025-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Magnesium SulfateHenry Schein, Inc.2025-10-31HUMAN PRESCRIPTION DRUG LABEL
Magnesium SulfateGeneral Injectables and Vaccines, Inc.2022-12-27HUMAN PRESCRIPTION DRUG LABEL
MAGNESIUM SULFATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-12-10HUMAN PRESCRIPTION DRUG LABEL
Magnesium Sulfate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2021-12-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-642-01Magnesium Sulfate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION203
63323-642-02Magnesium Sulfate50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION503
63323-642-20Magnesium Sulfate25 in 1 TRAYINJECTION, SOLUTION253
63323-642-50Magnesium Sulfate25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-642MAGNESIUM SULFATE (MAGNESIUM SULFATE HEPTAHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 4 package rows20211231_77f70e00-3934-4fd9-a581-4cf3df8c42d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-642-01ML - Milliliter63323-642578218da-5272-4988-b9c5-832b4ba6b5f512022-07-06
63323-642-02ML - Milliliter63323-642c3217431-9483-41a1-9a90-c1a6cd024cf312022-07-06
63323-642-20ML - Milliliter63323-642fa0d8848-a02a-442c-8c1b-185d23f9d5be12016-06-14
63323-642-50ML - Milliliter63323-642dba8c816-487e-4e61-99bf-7fc49cdf02bf12016-06-14

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 6 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLC77f70e00-3934-4fd9-a581-4cf3df8c42d22021-12-13Warnings, Adverse reactionsExact identifier
application number: NDA019316
ndc (package): 63323-642-20
ndc (package): 63323-642-02
ndc (package): 63323-642-50
ndc (package): 63323-642-01
ndc (product): 63323-642
ndc11 (package): 63323064201
rxcui: 1658245
rxcui: 1658236
spl id: 89d02988-a12e-4224-88f0-3f05f7ee324f
spl set id: 77f70e00-3934-4fd9-a581-4cf3df8c42d2
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLCb6352fbd-d3ee-2d3a-e053-2a95a90a747d2020-12-11Warnings, Adverse reactionsExact identifier
application number: NDA019316
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATESagent Pharmaceuticalsa607796c-6676-4d0a-8108-8708fe6769ed2020-11-16Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
MAGNESIUM SULFATEMAGNESIUM SULFATE HEPTAHYDRATEGland Pharma Limiteda9e706ac-9c5f-4b14-b277-53dee195ffc62020-07-14Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
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.