Prescription drug · ANDA
CycloSPORINE, Modfied (Cyclosporine) NDC 60505-4631
Cyclosporine 50 mg/1 · Capsule, Liquid filled · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4631-3 | 60505463103 | 30 BLISTER PACK in 1 CARTON (60505-4631-3) / 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Nov 5, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Modfied
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — 50 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210721
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-4631_deb75383-63a0-8509-1aee-0702c085a05eSPL ID deb75383-63a0-8509-1aee-0702c085a05eSPL set ID 5baaf78c-90f6-abcf-52c8-814490f3cf9fRxCUI 241834, 835894, 835925UNII 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
N460505463103followed by a unit qualifier and the quantityPackage 60505-4631-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Cyclosporine capsules (…
Excerpt only. Read the full label for complete information.
About NDC 60505-4631
- What is NDC 60505-4631?
- 60505-4631 is the product NDC for CycloSPORINE, Modfied (cyclosporine), Cyclosporine 50 mg/1 capsule, liquid filled, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CycloSPORINE, Modfied (Cyclosporine).
- What is the active ingredient?
- Cyclosporine.
- Who is the labeler?
- Apotex Corp., NDC labeler code 60505. 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, Modfied?
- 2 other product NDCs are listed under this name. See all CycloSPORINE, Modfied NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CycloSPORINE, Modfied products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| CycloSPORINE, Modfiedcyclosporine | Cyclosporine 25 mg/1 | Capsule, Liquid filledOral | Apotex Corp. | 60505-4630 | 60505-4630-03 |
| CycloSPORINE, Modfiedcyclosporine | Cyclosporine 100 mg/1 | Capsule, Liquid filledOral | Apotex Corp. | 60505-4632 | 60505-4632-03 |
Other NDCs under ANDA 210721
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| CycloSPORINE, Modfiedcyclosporine | Cyclosporine 25 mg/1 | Capsule, Liquid filledOral | Apotex Corp. | 60505-4630 |
| CycloSPORINE, Modfiedcyclosporine | Cyclosporine 100 mg/1 | Capsule, Liquid filledOral | Apotex Corp. | 60505-4632 |