Prescription drug · BLA
Sevenfact NDC 71127-5000
coagulation factor viia recombinant human · Kit · Intravenous · Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71127-5000-1 | 71127500001 | 1 KIT in 1 PACKAGE (71127-5000-1) * 5 mL in 1 VIAL, SINGLE-DOSE (71127-5100-1) * 5.2 mL in 1 SYRINGE (71127-5200-1)Marketed from Dec 10, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Sevenfact
- Generic name (nonproprietary)
- coagulation factor viia recombinant human
- Dosage form
- Kit
- Route
- Intravenous
- Labeler
- Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)NDC labeler code 71127
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125641
- Marketing start
- Listing expires
- Identifiers
- Product ID 71127-5000_b468e3d0-7f2d-47fc-ae87-888cf8c3d7f6SPL ID b468e3d0-7f2d-47fc-ae87-888cf8c3d7f6SPL set ID b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6RxCUI 2386865, 2386870, 2386872, 2386874, 2696277, 2696279UPC 0371127510018, 0371127110010
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N471127500001followed by a unit qualifier and the quantityPackage 71127-5000-01. 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)
SEVENFACT is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. Limitation s of Use: SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency. SEVENFACT is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors ( 1 ). Limitation s of Use: SEVENFACT is not indicated for treatment of congenital factor VII deficiency.
Excerpt only. Read the full label for complete information.
About NDC 71127-5000
- What is NDC 71127-5000?
- 71127-5000 is the product NDC for Sevenfact kit, listed with the FDA by Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sevenfact (Coagulation Factor VIIa Recombinant Human).
- Who is the labeler?
- Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.), NDC labeler code 71127. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sevenfact?
- 2 other product NDCs are listed under this name. See all Sevenfact NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sevenfact products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sevenfactcoagulation factor viia recombinant human | — | KitIntravenous | Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.) | 71127-2000 | 71127-2000-01 |
| Sevenfactcoagulation factor viia recombinant human | — | KitIntravenous | Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.) | 71127-1000 | 71127-1000-01 |
Other NDCs under BLA 125641
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 |
|---|---|---|---|---|
| Sevenfactcoagulation factor viia recombinant human | — | KitIntravenous | Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.) | 71127-1000 |
| Sevenfactcoagulation factor viia recombinant human | — | KitIntravenous | Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.) | 71127-2000 |