Cyclosporine NDC 68084-921

NDC codes

FDA NDC Directory

Product NDC (as listed)68084-921Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68084-0921Add 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
68084-921-25	68084092125	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-921-25) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68084-921-95)Marketed from Nov 3, 2015

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): Cyclosporine
Generic name (nonproprietary): cyclosporine
Active ingredients: Cyclosporine — 100 mg/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: American Health Packaging
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065040
Marketing start: Nov 3, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 68084-921_1857b1ea-c3f7-696a-e063-6394a90ad6ebSPL ID 1857b1ea-c3f7-696a-e063-6394a90ad6ebSPL set ID a8e29b54-e4ab-4bb9-ab6c-e4414a3f025bRxCUI 197553, 328160UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468084092125 followed by a unit qualifier and the quantity

Package 68084-0921-25. 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 May 13, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cyclosporine capsules, (NON-MODIFIED) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065040

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

FDA NDC Directory listings under ANDA 065040
Product	Strength	Form · route	Labeler	Product NDC
Cyclosporine	Cyclosporine 25 mg/1	Capsule, Gelatin coatedOral	American Health Packaging	68084-879
Cyclosporine	Cyclosporine 25 mg/1	Capsule, Gelatin coatedOral	Apotex Corp.	60505-0133
Cyclosporine	Cyclosporine 100 mg/1	Capsule, Gelatin coatedOral	Apotex Corp.	60505-0134