BYFAVO
These highlights do not include all the information needed to use BYFAVO safely and effectively. See full prescribing information for BYFAVO. BYFAVO (remimazolam) for injection, for intravenous use, CIV Initial U.S. Approval: 2020
Approved
Approval ID
4e1838f2-b999-41a7-a761-d94f09aa531f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2023
Manufacturers
FDA
Acacia Pharma, Ltd.
DUNS: 779660930
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
remimazolam besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71390-011
Application NumberNDA212295
Product Classification
M
Marketing Category
C73594
G
Generic Name
remimazolam besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 29, 2021
FDA Product Classification
INGREDIENTS (5)
lactose monohydrateInactive
Quantity: 6.7 mg in 1 mL
Code: EWQ57Q8I5X
Classification: IACT
remimazolam besylateActive
Quantity: 2.5 mg in 1 mL
Code: 280XQ6482H
Classification: ACTIM
dextran 40Inactive
Quantity: 10 mg in 1 mL
Code: K3R6ZDH4DU
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT