FDA.reportPublic FDA data

BYFAVO

Product NDC
71390-011
11-digit product format
713900011
Labeler code
71390
Product ID
71390-011_4da618a9-2e04-4d75-922b-173d22b4e84c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
remimazolam besylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Acacia Pharma, Ltd.
Application
NDA212295
Marketing category
NDA
Marketing start
2020-10-06
Substance
REMIMAZOLAM BESYLATE
Active strength
2.5 mg/mL
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BYFAVO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REMIMAZOLAM BESYLATE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii280XQ6482H
Rxcui2383946, 2383951

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea3f06ab-885d-4f23-8b6e-9f0b063679b0Product name120210115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71390-011-00BYFAVO8 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,89
71390-011-11BYFAVO10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71390-011-00EA - Each71390-011eff79713-b93e-4339-bfb5-a533334e09c912021-01-08
71390-011-11EA - Each71390-0114cba416a-f3d7-40f7-b1b0-b7aa088a88c812021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71390-011BYFAVO (REMIMAZOLAM BESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACACIA PHARMA, LTD.]9Current NDC, Legacy NDC, 2 package rows20250228_4e1838f2-b999-41a7-a761-d94f09aa531f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2383951Byfavo 20 MG InjectionPSN4e1838f2-b999-41a7-a761-d94f09aa531f9
2383946remimazolam 20 MG InjectionPSN4e1838f2-b999-41a7-a761-d94f09aa531f9
2383951remimazolam 20 MG Injection [Byfavo]SBD4e1838f2-b999-41a7-a761-d94f09aa531f9
2383946remimazolam 20 MG InjectionSCD4e1838f2-b999-41a7-a761-d94f09aa531f9
2383951Byfavo 20 MG (equivalent to remimazolam besylate 27.2 MG) InjectionSY4e1838f2-b999-41a7-a761-d94f09aa531f9
2383946remimazolam 20 MG (equivalent to remimazolam besylate 27.2 MG) InjectionSY4e1838f2-b999-41a7-a761-d94f09aa531f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71390-011-00713900011008 mL in 1 VIAL8 mlHistorical
71390-011-117139000111110 VIAL in 1 CARTON (71390-011-11) / 8 mL in 1 VIAL (71390-011-00) 10 vial2020-10-060000-00-00NoNoCurrent