Cyclosporine NDC 75907-048

NDC codes

FDA NDC Directory

Product NDC (as listed)75907-048Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75907-0048Add 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
75907-048-30	75907004830	30 BLISTER PACK in 1 BOX (75907-048-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-048-81)Marketed from Jul 1, 2024

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, Liquid filled
Route: Oral
Labeler: Dr. Reddy's Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065044
Marketing start: Jul 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 75907-048_d94fae26-e557-7f8f-1755-846c8f091506SPL ID d94fae26-e557-7f8f-1755-846c8f091506SPL set ID 64ec430a-e930-145c-e766-13fb49b64644RxCUI 241834, 835894UNII 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

N475907004830 followed by a unit qualifier and the quantity

Package 75907-0048-30. 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 3, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] have been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, 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] …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065044

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

FDA NDC Directory listings under ANDA 065044
Product	Strength	Form · route	Labeler	Product NDC
Cyclosporine	Cyclosporine 25 mg/1	Capsule, Liquid filledOral	Dr. Reddy's Laboratories Inc	75907-047