Prescription drug · NDA AUTHORIZED GENERIC
Cyclosporine NDC 10702-808
Cyclosporine .5 mg/mL · Emulsion · Ophthalmic · KVK-TECH, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-808-03 | 1070208080310702080803 | 30 VIAL, SINGLE-USE in 1 TRAY (10702-808-03) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Feb 10, 2022 | |
| 10702-808-06 | 1070208080610702080806 | 60 VIAL, SINGLE-USE in 1 TRAY (10702-808-06) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Feb 10, 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)
- Cyclosporine
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — .5 mg/mL
- Dosage form
- Emulsion
- Route
- Ophthalmic
- Labeler
- KVK-TECH, INC.NDC labeler code 10702
- 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 10702-808_795f036f-ee97-42b7-bd36-fff9220ce428SPL ID 795f036f-ee97-42b7-bd36-fff9220ce428SPL set ID a7040dc6-063b-40ee-8f2a-153e87b08430RxCUI 2572292UNII 83HN0GTJ6DUPC 0310702808034, 0310702808065
- 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
N410702080803followed by a unit qualifier and the quantityPackage 10702-0808-03. 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)
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.
About NDC 10702-808
- What is NDC 10702-808?
- 10702-808 is the product NDC for Cyclosporine, Cyclosporine .5 mg/mL emulsion, listed with the FDA by KVK-TECH, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyclosporine.
- What is the active ingredient?
- Cyclosporine.
- Who is the labeler?
- KVK-TECH, INC., NDC labeler code 10702. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cyclosporine?
- 24 other product NDCs are listed under this name. See all Cyclosporine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cyclosporine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Cipla USA Inc. | 69097-292 | 69097-0292-0369097-0292-97 |
| Cyclosporine | Cyclosporine 25 mg/1 | Capsule, Liquid filledOral | Aurobindo Pharma Limited | 59651-927 | 59651-0927-03 |
| Cyclosporine | Cyclosporine 50 mg/1 | Capsule, Liquid filledOral | Aurobindo Pharma Limited | 59651-928 | 59651-0928-65 |
| Cyclosporine | Cyclosporine 100 mg/1 | Capsule, Liquid filledOral | Aurobindo Pharma Limited | 59651-929 | 59651-0929-65 |
| Cyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Upsher-Smith Laboratories, LLC | 24979-126 | 24979-0126-1824979-0126-19 |
| Cyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Saptalis Pharmaceuticals, LLC | 71656-012 | 71656-0012-3071656-0012-60 |
| Cyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Teva Pharmaceuticals, Inc. | 0480-4076 | 00480-4076-3000480-4076-60 |
| Cyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Devatis Inc. | 73043-005 | 73043-0005-0173043-0005-02 |
| Cyclosporine | Cyclosporine 25 mg/1 | Capsule, Liquid filledOral | Dr. Reddy's Laboratories Inc | 75907-047 | 75907-0047-30 |
| Cyclosporine | Cyclosporine 100 mg/1 | Capsule, Liquid filledOral | Dr. Reddy's Laboratories Inc | 75907-048 | 75907-0048-30 |
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 |
|---|---|---|---|---|
| Cyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Apotex Corp | 60505-6202 |
| Cyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Lupin Pharmaceuticals, Inc. | 68180-214 |
| Restasiscyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Allergan, Inc. | 0023-9163 |
| Restasiscyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | A-S Medication Solutions | 50090-4476 |
| Restasis MultiDosecyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Allergan, Inc. | 0023-5301 |