Restasis (cyclosporine) NDC 0023-9163

NDC codes

FDA NDC Directory

Product NDC (as listed)0023-9163Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00023-9163Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0023-9163-12	00023916312	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	00023916330	30 VIAL, SINGLE-USE in 1 TRAY (0023-9163-30) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Apr 1, 2003
0023-9163-60	00023916360	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.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050790
Marketing start: Apr 1, 2003
Listing expires: Dec 31, 2026
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

N400023916312 followed by a unit qualifier and the quantity

Package 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 Sep 9, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050790

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 050790
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
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Apotex Corp	60505-6202
Restasis MultiDosecyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Allergan, Inc.	0023-5301