Prescription drug · BLA
Cimerli (Ranibizumab-eqrn) NDC 61314-625
Ranibizumab .5 mg/.05mL · Injection, Solution · Intravitreal · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-625-94 | 6131406259461314062594 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61314-625-94) / .05 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 12, 2024 |
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)
- Cimerli
- Generic name (nonproprietary)
- ranibizumab-eqrn
- Active ingredients
- Ranibizumab — .5 mg/.05mL
- Dosage form
- Injection, Solution
- Route
- Intravitreal
- Labeler
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761165
- Marketing start
- Listing expires
- Other FDA classes
- Vascular Endothelial Growth Factor Inhibitors (Mechanism)
- Identifiers
- Product ID 61314-625_0bfab18c-289a-42a1-b426-0fc2274a7a3eSPL ID 0bfab18c-289a-42a1-b426-0fc2274a7a3eSPL set ID 4b383d74-4830-4587-95f7-c32a39268df7RxCUI 2612675, 2612681, 2612684, 2612687UNII 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
N461314062594followed by a unit qualifier and the quantityPackage 61314-0625-94. 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)
CIMERLI is indicated for the treatment of patients with: CIMERLI, 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 61314-625
- What is NDC 61314-625?
- 61314-625 is the product NDC for Cimerli (ranibizumab-eqrn), Ranibizumab .5 mg/.05mL injection, solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cimerli (Ranibizumab-eqrn).
- What is the active ingredient?
- Ranibizumab.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cimerli?
- 3 other product NDCs are listed under this name. See all Cimerli NDCs.
- Is there a related HCPCS / J-code?
- Yes: J2778, Injection, ranibizumab, 0.1 mg. See Billing references above.
Related NDCs: other Cimerli products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cimerliranibizumab-eqrn | Ranibizumab .3 mg/.05mL | Injection, SolutionIntravitreal | Sandoz Inc | 61314-624 | 61314-0624-94 |
| Cimerliranibizumab-eqrn | Ranibizumab .3 mg/.05mL | Injection, SolutionIntravitreal | Coherus BioSciences Inc | 70114-440 | 70114-0440-01 |
| Cimerliranibizumab-eqrn | Ranibizumab .5 mg/.05mL | Injection, SolutionIntravitreal | Coherus BioSciences Inc | 70114-441 | 70114-0441-01 |
Other NDCs under BLA 761165
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 |
|---|---|---|---|---|
| Cimerliranibizumab-eqrn | Ranibizumab .3 mg/.05mL | Injection, SolutionIntravitreal | Sandoz Inc | 61314-624 |
| Cimerliranibizumab-eqrn | Ranibizumab .3 mg/.05mL | Injection, SolutionIntravitreal | Coherus BioSciences Inc | 70114-440 |
| Cimerliranibizumab-eqrn | Ranibizumab .5 mg/.05mL | Injection, SolutionIntravitreal | Coherus BioSciences Inc | 70114-441 |