Cyclosporine Modified (cyclosporine) NDC 0093-9019

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-9019Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-9019Add 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
0093-9019-65	00093901965	30 BLISTER PACK in 1 CARTON (0093-9019-65) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9019-19)Marketed from Jun 8, 2021

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 ModifiedSuffix: Modified
Generic name (nonproprietary): cyclosporine
Active ingredients: Cyclosporine — 50 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065110
Marketing start: Jun 8, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0093-9019_d5d977b4-fc80-4e46-ab55-280fd6d4ea12SPL ID d5d977b4-fc80-4e46-ab55-280fd6d4ea12SPL set ID 2de1e8b1-625f-43ce-a1d5-d543be208b11RxCUI 241834, 835894, 835925UNII 83HN0GTJ6DUPC 0300939018658
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400093901965 followed by a unit qualifier and the quantity

Package 00093-9019-65. 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 Apr 1, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Cyclosporine capsules, USP MODIFIED are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP MODIFIED have been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules, USP MODIFIED are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules, USP MODIFIED can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Cyclospo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065110

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

FDA NDC Directory listings under ANDA 065110
Product	Strength	Form · route	Labeler	Product NDC
Cyclosporine Modifiedcyclosporine	Cyclosporine 25 mg/1	Capsule, Liquid filledOral	Teva Pharmaceuticals USA, Inc.	0093-9018
Cyclosporine Modifiedcyclosporine	Cyclosporine 100 mg/1	Capsule, Liquid filledOral	Teva Pharmaceuticals USA, Inc.	0093-9020