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 useInitial U.S. Approval: 2016
Approved
Approval ID
8f6c6588-77b6-40c7-a897-52e881854d7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2023
Manufacturers
FDA
Civica, Inc.
DUNS: 081373942
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 Code72572-150
Application NumberANDA209784
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ephedrine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 17, 2020
FDA Product Classification
INGREDIENTS (5)
EPHEDRINE SULFATEActive
Quantity: 50 mg in 1 mL
Code: U6X61U5ZEG
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT