Magnesium Sulfate
Magnesium Sulfate In Water For Injection Rx only Single-Dose Intravenous Bag For Intravenous Use Only
Approved
Approval ID
29241655-49c9-4bc4-89f2-79a0b24b562e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Magnesium Sulfate In Water For
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1720
Application NumberANDA216597
Product Classification
M
Marketing Category
C73584
G
Generic Name
Magnesium Sulfate In Water For
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM SULFATE HEPTAHYDRATEActive
Quantity: 40 mg in 1 mL
Code: SK47B8698T
Classification: ACTIB
Magnesium Sulfate In Water For
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1719
Application NumberANDA216597
Product Classification
M
Marketing Category
C73584
G
Generic Name
Magnesium Sulfate In Water For
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM SULFATE HEPTAHYDRATEActive
Quantity: 40 mg in 1 mL
Code: SK47B8698T
Classification: ACTIB