NDC Package 71390-011-11 Byfavo

Remimazolam Besylate Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
71390-011-11
Package Description:
10 VIAL in 1 CARTON / 8 mL in 1 VIAL (71390-011-00)
Product Code:
Proprietary Name:
Byfavo
Non-Proprietary Name:
Remimazolam Besylate
Substance Name:
Remimazolam Besylate
Usage Information:
BYFAVO™ is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
11-Digit NDC Billing Format:
71390001111
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2383946 - remimazolam 20 MG Injection
  • RxCUI: 2383946 - remimazolam 20 MG (equivalent to remimazolam besylate 27.2 MG) Injection
  • RxCUI: 2383951 - Byfavo 20 MG Injection
  • RxCUI: 2383951 - remimazolam 20 MG Injection [Byfavo]
  • RxCUI: 2383951 - Byfavo 20 MG (equivalent to remimazolam besylate 27.2 MG) Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Acacia Pharma, Ltd.
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA212295
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-06-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71390-011-11?

    The NDC Packaged Code 71390-011-11 is assigned to a package of 10 vial in 1 carton / 8 ml in 1 vial (71390-011-00) of Byfavo, a human prescription drug labeled by Acacia Pharma, Ltd.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 71390-011 included in the NDC Directory?

    Yes, Byfavo with product code 71390-011 is active and included in the NDC Directory. The product was first marketed by Acacia Pharma, Ltd. on October 06, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 71390-011-11?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 71390-011-11?

    The 11-digit format is 71390001111. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-271390-011-115-4-271390-0011-11