Prescription drug · ANDA
Cyclosporine NDC 75907-048
Cyclosporine 100 mg/1 · Capsule, Liquid filled · Oral · Dr. Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-048-30 | 7590700483075907004830 | 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 IncNDC labeler code 75907
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065044
- Marketing start
- Listing expires
- 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
N475907004830followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 75907-048
- What is NDC 75907-048?
- 75907-048 is the product NDC for Cyclosporine, Cyclosporine 100 mg/1 capsule, liquid filled, listed with the FDA by Dr. Reddy's Laboratories 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?
- Dr. Reddy's Laboratories Inc, NDC labeler code 75907. 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 25 mg/1 | Capsule, Liquid filledOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-837 | 23155-0837-30 |
Other NDCs under ANDA 065044
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 | Dr. Reddy's Laboratories Inc | 75907-047 |