NDC codes

FDA NDC Directory
Product NDC (as listed)64406-019Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64406-0019Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
64406-019-01644060019011 VIAL, SINGLE-DOSE in 1 CARTON (64406-019-01) / .05 mL in 1 VIAL, SINGLE-DOSE (64406-019-07)Marketed from Jun 1, 2022
64406-019-08644060019081 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
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.

How CPT relates to drug billing

NDC on a medical claim

N464406001901 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761202

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761202
ProductStrengthForm · routeLabelerProduct NDC
Byoovizranibizumab-nunaRanibizumab 10 mg/mLInjection, SolutionIntravitrealHarrow Eye, LLC82667-018

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in