Zulresso
These highlights do not include all the information needed to use ZULRESSO safely and effectively. See full prescribing information for ZULRESSO. ZULRESSO (brexanolone) injection, for intravenous use, CIV Initial U.S. Approval: 2019
Approved
Approval ID
b40f3b2a-1859-4ed6-8551-444300806d13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 20, 2022
Manufacturers
FDA
Sage Therapeutics, Inc.
DUNS: 968164959
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
brexanolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72152-547
Application NumberNDA211371
Product Classification
M
Marketing Category
C73594
G
Generic Name
brexanolone
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 20, 2022
FDA Product Classification
INGREDIENTS (4)
BREXANOLONEActive
Quantity: 5 mg in 1 mL
Code: S39XZ5QV8Y
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.265 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
BETADEX SULFOBUTYL ETHER SODIUMInactive
Quantity: 250 mg in 1 mL
Code: 2PP9364507
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 2.57 mg in 1 mL
Code: B22547B95K
Classification: IACT