Cyclosporine NDC 0378-8760

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8760Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8760Add 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
0378-8760-58	00378876058	6 POUCH in 1 CARTON (0378-8760-58) / 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Feb 3, 2022
0378-8760-91	00378876091	12 POUCH in 1 CARTON (0378-8760-91) / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USEMarketed from Feb 3, 2022

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): Cyclosporine
Generic name (nonproprietary): cyclosporine
Active ingredients: Cyclosporine — .5 mg/mL
Dosage form: Emulsion
Route: Ophthalmic
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205894
Marketing start: Feb 3, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0378-8760_da3fa070-b512-4568-871a-dc8d5a949d13SPL ID da3fa070-b512-4568-871a-dc8d5a949d13SPL set ID da3fa070-b512-4568-871a-dc8d5a949d13RxCUI 2572292UNII 83HN0GTJ6DUPC 0303788760587, 0303788760914
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

N400378876058 followed by a unit qualifier and the quantity

Package 00378-8760-58. 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.