Akovaz
These highlights do not include all the information needed to use AKOVAZ® safely and effectively. See full prescribing information for AKOVAZ. AKOVAZ (ephedrine sulfate injection) for intravenous use Initial U.S. Approval: 2016
Approved
Approval ID
e92f3eda-33eb-4b34-9e8b-db8d32a5dbd9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2020
Manufacturers
FDA
Exela Pharma Sciences, LLC
DUNS: 831274399
Products 2
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 Code51754-4250
Application NumberNDA208289
Product Classification
M
Marketing Category
C73594
G
Generic Name
ephedrine sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 27, 2020
FDA Product Classification
INGREDIENTS (3)
EPHEDRINE SULFATEActive
Quantity: 5 mg in 1 mL
Code: U6X61U5ZEG
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ephedrine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-4200
Application NumberNDA208289
Product Classification
M
Marketing Category
C73594
G
Generic Name
ephedrine sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 27, 2020
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