Prescription drug · NDA
Restasis (Cyclosporine) NDC 0023-9163
Cyclosporine .5 mg/mL · Emulsion · Ophthalmic · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-9163-12 | 0002391631200023916312 | 5 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Apr 1, 2003 · Sample package | |
| 0023-9163-30 | 0002391633000023916330 | 30 VIAL, SINGLE-USE in 1 TRAY (0023-9163-30) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Apr 1, 2003 | |
| 0023-9163-60 | 0002391636000023916360 | 60 VIAL, SINGLE-USE in 1 TRAY (0023-9163-60) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Apr 1, 2003 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Restasis
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — .5 mg/mL
- Dosage form
- Emulsion
- Route
- Ophthalmic
- Labeler
- Allergan, Inc.NDC labeler code 0023
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050790
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0023-9163_3b350ae7-28e6-4dbd-824c-d0fe46b81e5aSPL ID 3b350ae7-28e6-4dbd-824c-d0fe46b81e5aSPL set ID 8e24af2b-bc1c-4849-94f2-6df950cdca89RxCUI 2572292, 2572293UNII 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 products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400023916312followed by a unit qualifier and the quantityPackage 00023-9163-12. 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)
1 IN DICATIONS AND USAGE RESTASIS ® ophthalmic emulsion 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. RESTASIS 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 using punctal pl…
Excerpt only. Read the full label for complete information.
About NDC 0023-9163
- What is NDC 0023-9163?
- 0023-9163 is the product NDC for Restasis (cyclosporine), Cyclosporine .5 mg/mL emulsion, listed with the FDA by Allergan, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Restasis (Cyclosporine).
- What is the active ingredient?
- Cyclosporine.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Restasis?
- 1 other product NDC are listed under this name. See all Restasis NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Restasis products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Restasiscyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | A-S Medication Solutions | 50090-4476 | 50090-4476-00 |
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 | KVK-TECH, INC. | 10702-808 |
| 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 | A-S Medication Solutions | 50090-4476 |
| Restasis MultiDosecyclosporine | Cyclosporine .5 mg/mL | EmulsionOphthalmic | Allergan, Inc. | 0023-5301 |