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Magnesium Sulfate

Magnesium Sulfate

Approved
Approval ID

1080bcf3-add5-4e53-b33e-6125f0437b2f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 2, 2017

Manufacturers
FDA

Fresenius Kabi Norge AS

DUNS: 731170932

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

MAGNESIUM SULFATE HEPTAHYDRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66298-1060
Application NumberANDA206485
Product Classification
M
Marketing Category
C73584
G
Generic Name
MAGNESIUM SULFATE HEPTAHYDRATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 2, 2017
FDA Product Classification

INGREDIENTS (3)

SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MAGNESIUM SULFATE HEPTAHYDRATEActive
Quantity: 40 mg in 1 mL
Code: SK47B8698T
Classification: ACTIB

MAGNESIUM SULFATE HEPTAHYDRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66298-1070
Application NumberANDA206485
Product Classification
M
Marketing Category
C73584
G
Generic Name
MAGNESIUM SULFATE HEPTAHYDRATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 2, 2017
FDA Product Classification

INGREDIENTS (3)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
MAGNESIUM SULFATE HEPTAHYDRATEActive
Quantity: 80 mg in 1 mL
Code: SK47B8698T
Classification: ACTIB

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Magnesium Sulfate - FDA Drug Approval Details