FDA.reportPublic FDA data

NDC 0338-6353-01 - 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
0338-6353
Requested NDC
0338-6353-01
Package NDCs from labels
0338-6353-01, 0338-6353-40
Manufacturer
Baxter Healthcare Corporation | Bieffe Medital SA
Effective date
2026-01-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Magnesium Sulfate - Baxter Healthcare Corporation | Bieffe Medital SABaxter Healthcare Corporation | Bieffe Medital SA2026-01-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-6353-01Magnesium Sulfate100 mL in 1 BAGINJECTION, SOLUTION10012
0338-6353-40Magnesium Sulfate40 in 1 CARTONINJECTION, SOLUTION4012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-6353-01ML - Milliliter0338-6353cec5f71e-93f7-4423-8b28-a5f28882496012026-03-17
0338-6353-40ML - Milliliter0338-6353143a3ad2-80a3-486f-a3bb-9ee131c320fe12026-03-17

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 17 · 327 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium SulfateMAGNESIUM SULFATEHospira, Inc.e175d329-315f-4f3b-bb4c-06ad4e0429672026-02-12Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
365 Whole Foods Market Epsom SaltMAGNESIUM SULFATEWhole Foods Market, Inc.4147cdd0-57f6-3857-e063-6394a90afecb2026-02-12Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATEYour Military Exchanges27cff497-123c-424a-9c43-57740c00168b2026-02-12Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATEWalgreen Co.b5a02809-6e01-4e01-b1c3-2b10c5091a4e2026-02-12Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATERetail Business Services, LLC1a8b540c-b66e-4dca-b7af-23705ae247b62026-02-06Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATEPublix Super Markets, Inc.e985e071-5541-456e-ae4d-dba85287fe752026-02-05Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATEDiscount Drug Martb05a94d2-5cc6-4989-9fb8-096e54fa78522026-02-04Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATEGrocery Outlet, Inc.3dff4b00-e71a-1dc0-e063-6394a90a715f2026-02-04Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATEHARRIS TEETER73065a04-b7cd-437d-9624-f845f5ec93bf2026-02-04Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATEHy-Vee, Inc.44592ee0-13dd-57b1-e063-6394a90ab4022026-02-04Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Epsom SaltMAGNESIUM SULFATECVS Pharmacy, Inc.a78d991a-ba21-4bc4-b8f9-f8dafbddc28f2026-02-03Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
MAGNESIUM SULFATEMAGNESIUM SULFATE HEPTAHYDRATESun Pharmaceutical Industries, Inc.efadcb55-f935-4c60-b2e2-0a76b9194b502026-01-29Warnings, Adverse reactionsExact identifier
rxcui: 1658259
rxcui: 1658262
unii: SK47B8698T
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCe921a46b-9a5b-4163-9c88-224247541f142026-01-13Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium Sulfate in DextroseMAGNESIUM SULFATEWG Critical Care, LLC8da9c33f-e3cd-4026-b034-2b964401b3462026-01-12Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCe9c10579-29f3-4889-8881-0626f63968d42026-01-12Warnings, Adverse reactionsExact identifier
unii: SK47B8698T
Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEBaxter Healthcare Corporationea05b8f9-6e11-45c3-824a-4a78818019df2026-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA211966
ndc (package): 0338-1715-40
ndc (package): 0338-1708-40
ndc (package): 0338-6353-40
ndc (package): 0338-6353-01
ndc (package): 0338-1719-40
ndc (product): 0338-1719
ndc (product): 0338-1708
ndc (product): 0338-6353
ndc (product): 0338-1715
ndc11 (package): 00338635301
rxcui: 829734
rxcui: 1658259
rxcui: 1658262
rxcui: 2731632
spl id: 4607ad92-bf37-439d-92ec-51ee3cdf8318
spl set id: ea05b8f9-6e11-45c3-824a-4a78818019df
unii: SK47B8698T
Enviro Detox 6009ENVIRO DETOXProfessional Complementary Health Formulasa6aab63a-9313-4490-b3a4-0b08f7753cc52026-01-08WarningsExact identifier
unii: O40UQP6WCF
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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