Prescription drug · ANDA
Cyclosporine NDC 60505-0133
Cyclosporine 25 mg/1 · Capsule, Gelatin coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0133-0 | 6050501330060505013300 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0133-0)Marketed from May 29, 2002 |
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
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — 25 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065040
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-0133_561ed7a8-f342-f4fe-ce36-998d87c33e7fSPL ID 561ed7a8-f342-f4fe-ce36-998d87c33e7fSPL set ID bfca7088-fe93-abb9-3ec3-e6f5710a69c6RxCUI 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
N460505013300followed by a unit qualifier and the quantityPackage 60505-0133-00. 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 Cyclosporine capsules, (NON-MODIFIED), in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents.
Excerpt only. Read the full label for complete information.
About NDC 60505-0133
- What is NDC 60505-0133?
- 60505-0133 is the product NDC for Cyclosporine, Cyclosporine 25 mg/1 capsule, gelatin coated, 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.
- 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?
- 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.
Related NDCs: other Cyclosporine 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 | 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 |
Other NDCs under ANDA 065040
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 | Cyclosporine 100 mg/1 | Capsule, Gelatin coatedOral | Apotex Corp. | 60505-0134 |
| Cyclosporine | Cyclosporine 25 mg/1 | Capsule, Gelatin coatedOral | American Health Packaging | 68084-879 |
| Cyclosporine | Cyclosporine 100 mg/1 | Capsule, Gelatin coatedOral | American Health Packaging | 68084-921 |