Prescription drug · BLA
Ixinity (coagulation factor ix (recombinant)) NDC 59137-284
Kit · Medexus Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59137-284-05 | 59137028405 | 1 KIT in 1 CARTON (59137-284-05) * 5 mL in 1 VIAL (59137-272-01) * 5 mL in 1 SYRINGE (59137-280-01)Marketed from Jul 1, 2021 |
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)
- Ixinity
- Generic name (nonproprietary)
- coagulation factor ix (recombinant)
- Dosage form
- Kit
- Labeler
- Medexus Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125426
- Marketing start
- Listing expires
- Identifiers
- Product ID 59137-284_5e2b1242-2977-463b-ac2c-f89dadfba407SPL ID 5e2b1242-2977-463b-ac2c-f89dadfba407SPL set ID 26bc221d-c9bc-4aba-92f3-6c21acaaf194RxCUI 1666311, 1666328UPC 0059137275010, 0059137272019, 0059137271012, 0059137270015, 0059137276017, 0359137280015, 0059137277014
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N459137028405followed by a unit qualifier and the quantityPackage 59137-0284-05. 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 .
Indications (excerpt from the label)
IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B for: On-demand treatment and control of bleeding episodes Perioperative management Routine prophylaxis to reduce the frequency of bleeding episodes IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B [see Warnings and Precautions ( 5.3 ) ]. IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B for: On-demand treatment and control of bleeding episodes ( 1 ) Perioperative management ( 1 ) Routine prophylaxis to reduce the frequency of bleeding episo…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125426
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 |
|---|---|---|---|---|
| Ixinitycoagulation factor ix (recombinant) | — | Kit | Medexus Pharma, Inc. | 59137-282 |
| Ixinitycoagulation factor ix (recombinant) | — | Kit | Medexus Pharma, Inc. | 59137-283 |
| Ixinitycoagulation factor ix (recombinant) | — | Kit | Medexus Pharma, Inc. | 59137-287 |
| Ixinitycoagulation factor ix (recombinant) | — | Kit | Medexus Pharma, Inc. | 59137-288 |
| Ixinitycoagulation factor ix (recombinant) | — | Kit | Medexus Pharma, Inc. | 59137-289 |