Prescription drug · ANDA
Cyclosporine NDC 69097-292
Cyclosporine .5 mg/mL · Emulsion · Ophthalmic · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-292-03 | 6909702920369097029203 | 2 POUCH in 1 CARTON (69097-292-03) / 30 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USEMarketed from Sep 21, 2026 | |
| 69097-292-97 | 6909702929769097029297 | 1 POUCH in 1 CARTON (69097-292-97) / 30 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USEMarketed from Sep 21, 2026 |
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
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219288
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-292_4aa71224-130e-44e0-953c-1f6de85e6d22SPL ID 4aa71224-130e-44e0-953c-1f6de85e6d22
- 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
N469097029203followed by a unit qualifier and the quantityPackage 69097-0292-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 69097-292
- What is NDC 69097-292?
- 69097-292 is the product NDC for Cyclosporine, Cyclosporine .5 mg/mL emulsion, listed with the FDA by Cipla USA 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?
- Cipla USA Inc., NDC labeler code 69097. 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 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 |
| Cyclosporine | Cyclosporine 25 mg/1 | Capsule, Liquid filledOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-837 | 23155-0837-30 |