Prescription drug · NDA
Verkazia (Cyclosporine) NDC 65086-001
Cyclosporine 1 mg/mL · Emulsion · Ophthalmic, Topical · Santen Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65086-001-05 | 65086000105 | 1 POUCH in 1 CARTON (65086-001-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 1, 2022 · Sample package | |
| 65086-001-12 | 65086000112 | 24 POUCH in 1 CARTON (65086-001-12) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 1, 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)
- Verkazia
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — 1 mg/mL
- Dosage form
- Emulsion
- Route
- Ophthalmic, Topical
- Labeler
- Santen IncorporatedNDC labeler code 65086
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214965
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 65086-001_2becea0d-7cbe-6b23-e063-6294a90a5a67SPL ID 2becea0d-7cbe-6b23-e063-6294a90a5a67SPL set ID c795cd2f-89da-78e3-e053-2a95a90a9422RxCUI 2590608, 2590613UNII 83HN0GTJ6D
- Pharmacologic class
- Calcineurin Inhibitor Immunosuppressant
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 codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic, Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465086000105followed by a unit qualifier and the quantityPackage 65086-0001-05. 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)
Verkazia ophthalmic emulsion is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. Verkazia ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis in children and adults ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 65086-001
- What is NDC 65086-001?
- 65086-001 is the product NDC for Verkazia (cyclosporine), Cyclosporine 1 mg/mL emulsion, listed with the FDA by Santen Incorporated. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Verkazia (Cyclosporine).
- What is the active ingredient?
- Cyclosporine.
- Who is the labeler?
- Santen Incorporated, NDC labeler code 65086. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Verkazia?
- 1 other product NDC are listed under this name. See all Verkazia NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Verkazia products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Verkaziacyclosporine | Cyclosporine 1 mg/mL | EmulsionOphthalmic, Topical | Harrow Eye, LLC | 82667-014 | 82667-0014-0082667-0014-01 |
Other NDCs under NDA 214965
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 |
|---|---|---|---|---|
| Verkaziacyclosporine | Cyclosporine 1 mg/mL | EmulsionOphthalmic, Topical | Harrow Eye, LLC | 82667-014 |