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 3 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natural Relief Diarrhea ReliefALOE, CITRULLUS COLOCYNTHIS, CROTON TIGLIUM, LYCOPODIUM CLAVATUM, MAGNESIUM SULFATE HEPTAHYDRATE, PHOSPHORIC ACID, THUJA OCCIDENTALISTRP Company436de0c5-acd6-e32b-e063-6394a90aa2752025-11-12WarningsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATEHenry Schein, Inc.c255b8a9-68da-49c1-897b-bc18b731e4592025-10-31WarningsExact identifier
application number: NDA019316
ndc (package): 0404-9902-20
ndc (product): 0404-9902
rxcui: 1658236
spl id: 3eacd64d-fec5-4c18-a80a-d87231610738
spl set id: c255b8a9-68da-49c1-897b-bc18b731e459
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEHenry Schein, Inc.27a581a3-2342-4cc3-b90f-6c739bdf71202025-10-31Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATECivica, Inc.a5a9f565-639c-4b22-b9e5-718bac7cfcf32025-10-30Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATEHenry Schein, Inc.5176ed24-015e-43fe-9eb4-85098debf5f12025-10-14Warnings, Adverse reactionsExact identifier
application number: NDA019316
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEProPharma Distribution3f003556-d675-1cf9-e063-6294a90a2cc42025-09-17Warnings, Adverse reactionsExact identifier
application number: NDA019316
unii: SK47B8698T
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERAvenacy, LLCf50f4e06-288c-4b5e-9260-f3fe0a210c0c2025-09-15Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Rapidol Sal InglesaMAGNESIUM SULFATE HEPTAHYDRATEPharmadel LLC1d4ef5f0-54c5-4838-e063-6394a90a44a82025-07-28WarningsExact identifier
unii: SK47B8698T
MAGNESIA SULPHURICAMAGNESIUM SULFATE HEPTAHYDRATEBoiron3aae0abd-8d2e-2694-e063-6394a90a86472025-07-24Exact identifier
unii: SK47B8698T
Sal Inglesa EPSOM SALTMAGNESIUM SULFATE HEPTAHYDRATEMenper Distributors, Inc247aa3a3-d38f-4799-b44d-dfe18324fd0c2025-07-01WarningsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEProPharma Distribution386d55c9-aeac-5597-e063-6294a90a0afe2025-06-25Warnings, Adverse reactionsExact identifier
application number: NDA019316
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATECamber Pharmaceuticals, Inc.647ca293-9e68-4773-947a-0fb064aa6fd12025-06-04Warnings, Adverse reactionsExact identifier
rxcui: 1658245
rxcui: 1658236
unii: SK47B8698T
Magnesium Sulfate in WaterMAGNESIUM SULFATE HEPTAHYDRATEB. Braun Medical Inc.f5f6b4c9-4a68-4342-b1e4-f4b61b7fb9cb2025-05-23Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATECVS PHARMACY30ce5cbd-cc7a-0b2d-e063-6394a90a85202025-03-20WarningsExact identifier
unii: SK47B8698T
Bestmade Natural Products BM160AMYL NIT, FRAXINUS AM, GRAPHITES, MAG PHOS, MAG SULPH, PULSATILLA, SABINA, SULPHURBestmade Natural Products2e6cbe2b-9aad-f73e-e063-6294a90a5a532025-02-18WarningsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE IN WATER FORAmneal Pharmaceuticals LLC29241655-49c9-4bc4-89f2-79a0b24b562e2025-02-12Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
D-92CHELIDONIUM MAJUS, TURMERIC, MAGNESIUM SULFATE HEPTAHYDRATE, MERCURY, AND TARAXACUM OFFICINALEDNA Labs, Inc.bd1a13ab-710c-4f0e-9fcc-746258f3744c2025-01-13WarningsExact identifier
unii: SK47B8698T
Epsom SaltsMAGNESIUM SULFATENEW PRIDE CORPf6626023-4857-518b-e053-2a95a90a98212024-12-19WarningsExact identifier
unii: SK47B8698T

Reported adverse events (FAERS/openFDA)#

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