Plasma derivative · BLA
BeneFIX (Coagulation factor ix (recombinant)) NDC 58394-636
Kit · Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58394-636-03 | 5839406360358394063603 | 1 KIT in 1 CARTON (58394-636-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-136-03)Marketed from Jul 6, 2007 |
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)
- BeneFIX
- Generic name (nonproprietary)
- coagulation factor ix (recombinant)
- Dosage form
- Kit
- Labeler
- Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCNDC labeler code 58394
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103677
- Marketing start
- Listing expires
- Identifiers
- Product ID 58394-636_3b0657cb-0070-4c64-b72c-2518178805e7SPL ID 3b0657cb-0070-4c64-b72c-2518178805e7
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
N458394063603followed by a unit qualifier and the quantityPackage 58394-0636-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 58394-636
- What is NDC 58394-636?
- 58394-636 is the product NDC for BeneFIX (coagulation factor ix (recombinant)) kit, listed with the FDA by Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BeneFIX (Coagulation factor ix (recombinant)).
- Who is the labeler?
- Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, NDC labeler code 58394. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for BeneFIX?
- 4 other product NDCs are listed under this name. See all BeneFIX NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other BeneFIX products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| BeneFIXcoagulation factor ix (recombinant) | — | Kit | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-637 | 58394-0637-03 |
| BeneFIXcoagulation factor ix (recombinant) | — | Kit | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-633 | 58394-0633-03 |
| BeneFIXcoagulation factor ix (recombinant) | — | Kit | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-634 | 58394-0634-03 |
| BeneFIXcoagulation factor ix (recombinant) | — | Kit | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-635 | 58394-0635-03 |
Other NDCs under BLA 103677
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 |
|---|---|---|---|---|
| BeneFIXcoagulation factor ix (recombinant) | — | Kit | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-633 |
| BeneFIXcoagulation factor ix (recombinant) | — | Kit | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-634 |
| BeneFIXcoagulation factor ix (recombinant) | — | Kit | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-635 |
| BeneFIXcoagulation factor ix (recombinant) | — | Kit | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 58394-637 |