Prescription drug · BLA
Byooviz (Ranibizumab-nuna) NDC 64406-019
Ranibizumab 10 mg/mL · Injection, Solution · Intravitreal · BIOGEN INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64406-019-01 | 6440600190164406001901 | 1 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-01) / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-07)Marketed from Jun 1, 2022 | |
| 64406-019-08 | 6440600190864406001908 | 1 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-08) / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-09)Marketed from Oct 3, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Byooviz
- Generic name (nonproprietary)
- ranibizumab-nuna
- Active ingredients
- Ranibizumab — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravitreal
- Labeler
- BIOGEN INC.NDC labeler code 64406
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761202
- Marketing start
- Marketing end
- Other FDA classes
- Vascular Endothelial Growth Factor Inhibitors (Mechanism)
- Identifiers
- Product ID 64406-019_44ead429-973b-60cb-e063-6394a90a9a75SPL ID 44ead429-973b-60cb-e063-6394a90a9a75SPL set ID e46db299-edd1-4457-89b2-c1e2e505f1b0RxCUI 2602353, 2602359UNII ZL1R02VT79
- Pharmacologic class
- Vascular Endothelial Growth Factor Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeMed-Code curated
J2778 — Injection, ranibizumab, 0.1 mg
Billing unit: 0.1 mg. Units on the claim = dose given ÷ 0.1 mg.
Ranibizumab biosimilars and the ranibizumab implant have their own HCPCS codes.
- Administration
Intravitreal injection procedure (CPT 67028)
The intravitreal injection is reported as a separate procedure from the drug supplied.
- NDC on a medical claim
N464406001901followed by a unit qualifier and the quantityPackage 64406-0019-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
BYOOVIZ is indicated for the treatment of patients with: BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) Myopic Choroidal Neovascularization (mCNV) ( 1.3 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Myopic Choroidal Neovascularization (mCNV)
Excerpt only. Read the full label for complete information.
About NDC 64406-019
- What is NDC 64406-019?
- 64406-019 is the product NDC for Byooviz (ranibizumab-nuna), Ranibizumab 10 mg/mL injection, solution, listed with the FDA by BIOGEN INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Byooviz (Ranibizumab-nuna).
- What is the active ingredient?
- Ranibizumab.
- Who is the labeler?
- BIOGEN INC., NDC labeler code 64406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Byooviz?
- 1 other product NDC are listed under this name. See all Byooviz NDCs.
- Is there a related HCPCS / J-code?
- Yes: J2778, Injection, ranibizumab, 0.1 mg. See Billing references above.
Related NDCs: other Byooviz products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Byoovizranibizumab-nuna | Ranibizumab 10 mg/mL | Injection, SolutionIntravitreal | Harrow Eye, LLC | 82667-018 | 82667-0018-05 |
Other NDCs under BLA 761202
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Byoovizranibizumab-nuna | Ranibizumab 10 mg/mL | Injection, SolutionIntravitreal | Harrow Eye, LLC | 82667-018 |