Cimerli (ranibizumab-eqrn) NDC 61314-625

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-625Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0625Add 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 NDC	11-digit (billing)	Package	Copy
61314-625-94	61314062594	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 Inc
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761165
Marketing start: Dec 12, 2024
Listing expires: Dec 31, 2026
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.

How CPT relates to drug billing

NDC on a medical claim

N461314062594 followed by a unit qualifier and the quantity

Package 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 Jun 17, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761165

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

FDA NDC Directory listings under BLA 761165
Product	Strength	Form · route	Labeler	Product NDC
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
Cimerliranibizumab-eqrn	Ranibizumab .3 mg/.05mL	Injection, SolutionIntravitreal	Sandoz Inc	61314-624