Prescription drug · ANDA
Gengraf (Cyclosporine) NDC 0074-3108
Cyclosporine 25 mg/1 · Capsule · Oral · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-3108-32 | 0007431083200074310832 | 3 BLISTER PACK in 1 CARTON (0074-3108-32) / 10 CAPSULE in 1 BLISTER PACKMarketed from Nov 1, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Gengraf
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065003
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0074-3108_38f517b9-c5d1-479a-9117-f65ea1d479d4SPL ID 38f517b9-c5d1-479a-9117-f65ea1d479d4SPL set ID e896cbfe-4745-4088-82a3-8dc10b75c41fRxCUI 241834, 835835, 835894, 835896, 835925, 1797521UNII 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
N400074310832followed by a unit qualifier and the quantityPackage 00074-3108-32. 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 Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine ( MODIFIED ) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Gengraf ® Capsules (cyclosporine capsules, USP [ MODIFIED ]) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Gengraf ® can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psorias…
Excerpt only. Read the full label for complete information.
About NDC 0074-3108
- What is NDC 0074-3108?
- 0074-3108 is the product NDC for Gengraf (cyclosporine), Cyclosporine 25 mg/1 capsule, listed with the FDA by AbbVie Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gengraf (Cyclosporine).
- What is the active ingredient?
- Cyclosporine.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gengraf?
- 1 other product NDC are listed under this name. See all Gengraf NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gengraf products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gengrafcyclosporine | Cyclosporine 100 mg/1 | CapsuleOral | AbbVie Inc. | 0074-3109 | 00074-3109-32 |
Other NDCs under ANDA 065003
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 |
|---|---|---|---|---|
| Gengrafcyclosporine | Cyclosporine 100 mg/1 | CapsuleOral | AbbVie Inc. | 0074-3109 |