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 4 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 1658259
unii: SK47B8698T
Skinade MD INsupportARNICA, LEDUM, CALENDULA, BELLIS PERENNIS, HYPERICUM PERF. SULPH.AC., THIOSINAMINUM, VIT.K1Bottled Science, Inc.eb0069b3-8f68-3f41-e053-2995a90adbac2025-10-16WarningsExact identifier
unii: O40UQP6WCF
Magnesium SulfateMAGNESIUM SULFATEHenry Schein, Inc.5176ed24-015e-43fe-9eb4-85098debf5f12025-10-14Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEProPharma Distribution3f003556-d675-1cf9-e063-6294a90a2cc42025-09-17Warnings, Adverse reactionsExact identifier
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
rxcui: 829734
rxcui: 1658259
rxcui: 1658262
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
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.93e05175-001b-c639-e053-2a95a90a289c2025-08-19WarningsExact identifier
unii: O40UQP6WCF
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.9b4276af-b738-3293-e053-2a95a90ad0222025-08-19WarningsExact identifier
unii: O40UQP6WCF
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
PhytogelARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, LEDUM PALUSTRE, NATRUM SULPHURICUM, RHUS TOX, SULPHURICUM ACIDUM, SYMPHYTUM OFFICINALEEnergetix Corporatione94b4f4c-bf4e-4210-a4e1-f2b7341e6dcc2025-07-15WarningsExact identifier
unii: O40UQP6WCF
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
unii: SK47B8698T
MenopauseANGELICA ARCHANGELICA, ARALIA QUINQUEFOLIA, CIMICIFUGA RACEMOSA, HYDRASTIS CANADENSIS, PULSATILLA, SABINA, SEPIA, SULPHURICUM ACIDUM, LACHESIS MUTUSBioActive Nutritional, Inc.03ce1f50-6af5-4640-825f-67fcb25e76e62025-06-24WarningsExact identifier
unii: O40UQP6WCF
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATECamber Pharmaceuticals, Inc.647ca293-9e68-4773-947a-0fb064aa6fd12025-06-04Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
MYCCombinationALLIUM CEPA, ECHINACEA (ECHINACEA ANGUSTIFOLIA), NATRUM SULPHURICUM, KALI CARBONICUM, SANGUINARIA CANADENSIS, AGARICUS MUSCARIUS, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, PHYTOLACCA DECANDRA, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS, AMMONIUM CARBONICUM, ASPERGILLUS NIGER, BLATTA ORIENTALIS, MEPHITIS MEPHITICADeseret Biologicals, Inc.22b6a444-68de-43a3-85e8-e8a74b3914bc2025-05-27WarningsExact identifier
unii: O40UQP6WCF
Magnesium Sulfate in WaterMAGNESIUM SULFATE HEPTAHYDRATEB. Braun Medical Inc.f5f6b4c9-4a68-4342-b1e4-f4b61b7fb9cb2025-05-23Warnings, Adverse reactionsExact identifier
rxcui: 829734
rxcui: 1658259
rxcui: 1658262
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATECVS PHARMACY30ce5cbd-cc7a-0b2d-e063-6394a90a85202025-03-20WarningsExact identifier
unii: SK47B8698T

Reported adverse events (FAERS/openFDA)#

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