Prescription drug · NDA AUTHORIZED GENERIC
Cyclosporine NDC 60505-6202
Cyclosporine .5 mg/mL · Emulsion · Ophthalmic · Apotex Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-6202-1 | 60505620201 | 30 VIAL in 1 TRAY (60505-6202-1) / .4 mL in 1 VIALMarketed from Feb 7, 2022 | |
| 60505-6202-2 | 60505620202 | 60 VIAL in 1 TRAY (60505-6202-2) / .4 mL in 1 VIALMarketed from Feb 7, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Cyclosporine
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — .5 mg/mL
- Dosage form
- Emulsion
- Route
- Ophthalmic
- Labeler
- Apotex Corp
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050790
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-6202_58c5fb86-01c3-497b-86f7-a65055732970SPL ID 58c5fb86-01c3-497b-86f7-a65055732970SPL set ID 70c8a4a6-ebe2-457f-a626-400c338cec2dRxCUI 2572292UNII 83HN0GTJ6DUPC 0360505620227, 0360505620210
- 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 products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460505620201followed by a unit qualifier and the quantityPackage 60505-6202-01. 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)
Cyclosporine ophthalmic emulsion, 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. Cyclosporine ophthalmic emulsion, 0.05% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or u…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 050790
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 |
|---|---|---|---|---|
| Restasiscyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | A-S Medication Solutions | 50090-4476 |
| Cyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | KVK-TECH, INC. | 10702-808 |
| Cyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Lupin Pharmaceuticals, Inc. | 68180-214 |
| Restasiscyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Allergan, Inc. | 0023-9163 |
| Restasis MultiDosecyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Allergan, Inc. | 0023-5301 |