Cequa (cyclosporine) NDC 47335-507

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-507Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0507Add 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
47335-507-97	47335050797	1 POUCH in 1 BOX (47335-507-97) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 15, 2018 · Sample package

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): Cequa
Generic name (nonproprietary): cyclosporine
Active ingredients: Cyclosporine — .0009 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic, Topical
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 210913
Marketing start: Aug 15, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 47335-507_0c4be5cb-4e73-413f-847c-66babed20757SPL ID 0c4be5cb-4e73-413f-847c-66babed20757SPL set ID 48c3d8a3-4289-4b52-9189-58b48596095cRxCUI 2055021, 2055026UNII 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, Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N447335050797 followed by a unit qualifier and the quantity

Package 47335-0507-97. 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 Jun 15, 2026.

Indications (excerpt from the label)

CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). ( 1 ) CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye) ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 210913

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

FDA NDC Directory listings under NDA 210913
Product	Strength	Form · route	Labeler	Product NDC
Cequacyclosporine	Cyclosporine .0009 g/mL	Solution/ dropsOphthalmic, Topical	Sun Pharmaceutical Industries, Inc.	47335-506