Byooviz Injection, Solution
NDC Package 64406-019-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Byooviz (ranibizumab-nuna) injection is a medication used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema, diabetic retinopathy). This formulation utilizes a injection, solution delivery system. Marketed by Biogen Inc., this product is identified by NDC 64406-019 and is authorized under FDA application BLA761202.

Identification & Billing

NDC Package Code
64406-019-08
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-09)
Product Code
64406-019
11-Digit Billing Format
64406001908
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Byooviz
Non-Proprietary Name
Ranibizumab-nuna
Substance Name
Ranibizumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravitreal - Administration within the vitreous body of the eye.
Active Ingredient(s)
RANIBIZUMAB 10 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema, diabetic retinopathy). It is used to help prevent decreased vision and blindness. Ranibizumab works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

Regulatory & Marketing

Labeler Name
Biogen Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761202
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-01-2022
End Marketing Date
07-19-2028
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64406-019). Click a package code to view its specific billing and regulatory data.

64406-019-01
1 VIAL, SINGLE-DOSE in 1 CARTON / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-07)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64406-019-08 identifies a specific commercial package of 1 vial, single-dose in 1 carton / .05 ml in 1 vial, single-dose (64406-019-09) of Byooviz, a human prescription drug labeled by Biogen Inc.. This injection, solution is formulated for intravitreal use and contains ranibizumab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Biogen Inc. on June 01, 2022.

What are the primary indications for this medication?

This medication is used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema, diabetic retinopathy). It is used to help prevent decreased vision and blindness. Ranibizumab works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

How is this Biogen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64406001908. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
64406-019-08
11-Digit CMS (5-4-2)
64406-0019-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.