Restasis (cyclosporine) NDC 50090-4476

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-4476Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-4476Add 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	Copy
50090-4476-0	50090447600	30 VIAL, SINGLE-USE in 1 TRAY (50090-4476-0) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Aug 26, 2019

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): Restasis
Generic name (nonproprietary): cyclosporine
Active ingredients: Cyclosporine — .5 mg/mL
Dosage form: Emulsion
Route: Ophthalmic
Labeler: A-S Medication Solutions
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 50090-4476_0a22357f-0136-44d5-ab37-0a7d15287b30SPL ID 0a22357f-0136-44d5-ab37-0a7d15287b30SPL set ID ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03RxCUI 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

N450090447600 followed by a unit qualifier and the quantity

Package 50090-4476-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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
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
Restasiscyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Allergan, Inc.	0023-9163
Restasis MultiDosecyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Allergan, Inc.	0023-5301