What is NDC 68084-879?

68084-879 is the product NDC for Cyclosporine, Cyclosporine 25 mg/1 capsule, gelatin coated, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.

American Health Packaging, NDC labeler code 68084. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cyclosporine?

24 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cyclosporine NDC 68084-879 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68084-879Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68084-0879Add 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
68084-879-25	68084087925	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-879-25) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68084-879-95)Marketed from Sep 30, 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 — 25 mg/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: American Health PackagingNDC labeler code 68084
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065040
Marketing start: Sep 30, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 68084-879_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

N468084087925 followed by a unit qualifier and the quantity

Package 68084-0879-25. 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)

About NDC 68084-879

What is NDC 68084-879?: 68084-879 is the product NDC for Cyclosporine, Cyclosporine 25 mg/1 capsule, gelatin coated, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cyclosporine.
What is the active ingredient?: Cyclosporine.
Who is the labeler?: American Health Packaging, NDC labeler code 68084. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cyclosporine?: 24 other product NDCs are listed under this name. See all Cyclosporine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cyclosporine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Cipla USA Inc.	69097-292	69097-0292-0369097-0292-97
Cyclosporine	Cyclosporine 25 mg/1	Capsule, Liquid filledOral	Aurobindo Pharma Limited	59651-927	59651-0927-03
Cyclosporine	Cyclosporine 50 mg/1	Capsule, Liquid filledOral	Aurobindo Pharma Limited	59651-928	59651-0928-65
Cyclosporine	Cyclosporine 100 mg/1	Capsule, Liquid filledOral	Aurobindo Pharma Limited	59651-929	59651-0929-65
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Upsher-Smith Laboratories, LLC	24979-126	24979-0126-1824979-0126-19
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Saptalis Pharmaceuticals, LLC	71656-012	71656-0012-3071656-0012-60
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Teva Pharmaceuticals, Inc.	0480-4076	00480-4076-3000480-4076-60
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Devatis Inc.	73043-005	73043-0005-0173043-0005-02
Cyclosporine	Cyclosporine 25 mg/1	Capsule, Liquid filledOral	Dr. Reddy's Laboratories Inc	75907-047	75907-0047-30
Cyclosporine	Cyclosporine 100 mg/1	Capsule, Liquid filledOral	Dr. Reddy's Laboratories Inc	75907-048	75907-0048-30

All 25 Cyclosporine NDCs

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 100 mg/1	Capsule, Gelatin coatedOral	American Health Packaging	68084-921
Cyclosporine	Cyclosporine 25 mg/1	Capsule, Gelatin coatedOral	Apotex Corp.	60505-0133
Cyclosporine	Cyclosporine 100 mg/1	Capsule, Gelatin coatedOral	Apotex Corp.	60505-0134