Prescription drug · BLA
Lucentis (Ranibizumab) NDC 50242-080
Ranibizumab 10 mg/mL · Injection, Solution · Intravitreal · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-080-03 | 50242008003 | 1 SYRINGE, GLASS in 1 CARTON (50242-080-03) / .05 mL in 1 SYRINGE, GLASSMarketed from Oct 13, 2016 | |
| 50242-080-88 | 50242008088 | 1 SYRINGE, GLASS in 1 CARTON (50242-080-88) / .05 mL in 1 SYRINGE, GLASSMarketed from Oct 13, 2016 · Sample package |
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)
- Lucentis
- Generic name (nonproprietary)
- ranibizumab
- Active ingredients
- Ranibizumab — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravitreal
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125156
- Marketing start
- Listing expires
- Other FDA classes
- Vascular Endothelial Growth Factor Inhibitors (Mechanism)
- Identifiers
- Product ID 50242-080_71a6df7b-906b-4de9-ad4f-200285958cdcSPL ID 71a6df7b-906b-4de9-ad4f-200285958cdcSPL set ID de4e66cc-ca05-4dc9-8262-e00e9b41c36dRxCUI 1864423, 1864425, 2045501, 2045502UNII 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
N450242008003followed by a unit qualifier and the quantityPackage 50242-0080-03. 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)
LUCENTIS is indicated for the treatment of patients with: LUCENTIS, 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 ) Diabetic Macular Edema (DME) ( 1.3 ) Diabetic Retinopathy (DR) ( 1.4 ) Myopic Choroidal Neovascularization (mCNV) ( 1.5 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) 1.4 Diabetic Retinopathy (DR) 1.5 Myopic Choroidal Neovascularization (mCNV)
Excerpt only. Read the full label for complete information.
About NDC 50242-080
- What is NDC 50242-080?
- 50242-080 is the product NDC for Lucentis (ranibizumab), Ranibizumab 10 mg/mL injection, solution, listed with the FDA by Genentech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lucentis (Ranibizumab).
- What is the active ingredient?
- Ranibizumab.
- Who is the labeler?
- Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lucentis?
- 1 other product NDC are listed under this name. See all Lucentis NDCs.
- Is there a related HCPCS / J-code?
- Yes: J2778, Injection, ranibizumab, 0.1 mg. See Billing references above.
Related NDCs: other Lucentis products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lucentisranibizumab | Ranibizumab 6 mg/mL | Injection, SolutionIntravitreal | Genentech, Inc. | 50242-082 | 50242-0082-0350242-0082-88 |
Other NDCs under BLA 125156
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 |
|---|---|---|---|---|
| Lucentisranibizumab | Ranibizumab 6 mg/mL | Injection, SolutionIntravitreal | Genentech, Inc. | 50242-082 |