Ephedrine Sulfate
These highlights do not include all the information needed to use EPHEDRINE SULFATE INJECTION safely and effectively. See full prescribing information for EPHEDRINE SULFATE INJECTION. EPHEDRINE SULFATE injection for intravenous use Initial U.S. Approval: 2016
Approved
Approval ID
4a66e6c1-6d01-46fa-a2da-566fbf6e11a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2022
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ephedrine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-495
Application NumberANDA216146
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ephedrine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 12, 2022
FDA Product Classification
INGREDIENTS (4)
EPHEDRINE SULFATEActive
Quantity: 50 mg in 1 mL
Code: U6X61U5ZEG
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT