Prescription drug · ANDA
Cyclosporine NDC 23155-838
Cyclosporine 50 mg/1 · Capsule, Liquid filled · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-838-30 | 2315508383023155083830 | 6 BLISTER PACK in 1 CARTON (23155-838-30) / 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-838-11)Marketed from Nov 30, 2022 |
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 — 50 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDC labeler code 23155
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216046
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 23155-838_15185077-eec3-40ca-a492-f500a05a045bSPL ID 15185077-eec3-40ca-a492-f500a05a045bSPL set ID 1952d4c7-a40e-4924-b669-c41400774cb9RxCUI 241834, 835894, 835925UNII 83HN0GTJ6DUPC 0323155839302
- 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
N423155083830followed by a unit qualifier and the quantityPackage 23155-0838-30. 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 . 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 23155-838
- What is NDC 23155-838?
- 23155-838 is the product NDC for Cyclosporine, Cyclosporine 50 mg/1 capsule, liquid filled, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. 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?
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 23155. 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 216046
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 25 mg/1 | Capsule, Liquid filledOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-837 |
| Cyclosporine | Cyclosporine 100 mg/1 | Capsule, Liquid filledOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-839 |
| Cyclosporine | Cyclosporine 25 mg/1 | Capsule, Liquid filledOral | Strides Pharma Science Limited | 64380-127 |
| Cyclosporine | Cyclosporine 50 mg/1 | Capsule, Liquid filledOral | Strides Pharma Science Limited | 64380-128 |
| Cyclosporine | Cyclosporine 100 mg/1 | Capsule, Liquid filledOral | Strides Pharma Science Limited | 64380-129 |