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 6 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATETarget Corporation2540ae39-2218-0f6a-e063-6294a90a5efc2024-10-24WarningsExact identifier
unii: SK47B8698T
ProgeniteAMMONIUM CARBONICUM, BARYTA MURIATICA, BORAX, CAULOPHYLLUM THALICTROIDES, NATRUM CARBONICUM, SABAL SERRULATA, SABINA, SULPHURICUM ACIDUM, THIOSINAMINUM, FOLLICULINUM, TUBA UTERINA SUIS, UTERUS SUIS, HYPOTHALAMUS (SUIS), THYROIDINUM (SUIS), AGNUS CASTUS, CONIUM MACULATUM, GRAPHITES, HYOSCYAMUS NIGER, SEPIA, SELENIUM METALLICUM, X-RAYDeseret Biologicalsdfc114e0-34d4-4ae4-bba8-a8a1b7ad6a242024-10-23WarningsExact identifier
unii: O40UQP6WCF
DexatranMULTIVITAMINPureTek Corporatione052d2c2-7a3f-37be-e053-2a95a90af21c2024-09-13Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
MAGNESIUM SULFATE IN DEXTROSEMAGNESIUM SULFATE IN DEXTROSEBaxter Healthcare Corporation1bbaebd0-3f4c-467d-96fd-69cfad5a3fd32024-08-30Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Mind Detox and DrainageALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUMDeseret Biologicals, Inc.1ac1e955-a374-4cac-b997-51c6aef8d35d2024-08-01WarningsExact identifier
unii: O40UQP6WCF
Theraworx Relief Muscle Cramp and Spasm ReliefMAGNESIUM SULFATE HEPTAHYDRATEAVADIM HOLDINGS, INC.d87274cf-97b5-4965-9187-caec621e61772024-07-01WarningsExact identifier
unii: SK47B8698T
Theraworx ReliefMAGNESIUM SULFATE HEPTAHYDRATEAVADIM HOLDINGS, INC.2da384c4-3559-45aa-a7db-4e2269e33fa72024-06-18WarningsExact identifier
unii: SK47B8698T
Theraworx Relief Muscle Cramp and Spasm ReliefMAGNESIUM SULFATE HEPTAHYDRATEAVADIM HOLDINGS, INCde5c58fb-2ce7-4beb-bc37-26d7cf0e8a782024-06-18WarningsExact identifier
unii: SK47B8698T
magnesium sulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCfef9e18c-5210-4090-b564-4950ebe461c02024-04-24Warnings, Adverse reactionsExact identifier
application number: ANDA206485
ndc (package): 63323-106-00
ndc (package): 63323-106-05
ndc (package): 63323-106-15
ndc (package): 63323-106-10
ndc (package): 63323-107-05
ndc (package): 63323-106-02
ndc (package): 63323-107-01
ndc (package): 63323-106-01
ndc (product): 63323-107
ndc (product): 63323-106
ndc11 (package): 63323010701
rxcui: 1658265
rxcui: 829734
rxcui: 1658259
rxcui: 1658264
rxcui: 1658262
spl id: 48486022-130e-4a6a-87e7-db7c53eb5e75
spl set id: fef9e18c-5210-4090-b564-4950ebe461c0
unii: SK47B8698T
magnesium sulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLC43d658b1-2b19-44be-a346-cac11fd600b32024-04-24Warnings, Adverse reactionsExact identifier
application number: ANDA206485
ndc (product): 63323-106
rxcui: 1658265
rxcui: 1658259
rxcui: 1658264
rxcui: 1658262
spl id: 5199cf86-058a-4ad5-961b-eaba5e350e99
spl set id: 43d658b1-2b19-44be-a346-cac11fd600b3
unii: SK47B8698T
Magnesium Sulfate in 5% DextroseMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCcea3f48b-375a-415a-a341-435c09719f7c2024-04-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium Sulfate in 5% DextroseMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCfdffb339-89d1-4495-97b7-d9422d68b3d52024-04-24Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: SK47B8698T
HerXECHINACEA (ANGUSTIFOLIA), ARNICA MONTANA, HYDRASTIS CANADENSIS, LEDUM PALUSTRE, MAGNESIA SULPHURICA, KALMIA LATIFOLIA, ARSENICUM ALBUM, COCCULUS INDICUS, PHOSPHORUSDeseret Biologicals, Incae270bbf-40c8-44e9-91ea-ee5ddbdd9f542024-03-11WarningsExact identifier
unii: SK47B8698T
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: O40UQP6WCF
Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERAthenex Pharmaceutical Division, LLC.70776952-a340-4405-9cf0-f0988ff8097b2024-03-04Warnings, Adverse reactionsExact identifier
rxcui: 829734
rxcui: 1658259
rxcui: 1658262
unii: SK47B8698T
MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirst7d94995b-9e2a-0345-e053-2991aa0a62d02024-01-28Warnings, Adverse reactionsExact identifier
rxcui: 1658259
unii: SK47B8698T
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: SK47B8698T
N02 PETROCHEMACETONE, ANILINUM, BENZINUM, BENZOPYRENE, CARBO VEGETABILIS, CARBOLICUM ACIDUM, CARBON TETRACHLORIDE, ETHER, MAGNESIA SULPHURICA, METHYL ALCOHOL, PETROLEUM, PHENOLPHTHALEIN, PHOSPHORUS, PICRICUM ACIDUM, PINE TAR, PLUMBOUS CHLORIDE, PLUMBUM METALLICUM, SULPHONALUM, SULPHURICUM ACIDUM, TEREBINTHINA, TRICHLOROETHYLENE, VANADIUM METALLICUMApex Energetics Inc.ba5e7801-667b-ab7c-e053-2995a90a788c2024-01-08WarningsExact identifier
unii: SK47B8698T
unii: O40UQP6WCF
Humco Epson SaltMAGNESIUM SULFATEHumco Holding Group, Inc.7a9d1b77-6c39-46f1-86f2-4059dde20f852023-12-15WarningsExact identifier
unii: SK47B8698T

Reported adverse events (FAERS/openFDA)#

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