NDC codes

FDA NDC Directory
Product NDC (as listed)71127-5000Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71127-5000Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71127-5000-1711275000011 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
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.

How CPT relates to drug billing

NDC on a medical claim

N471127500001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sevenfact NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sevenfactcoagulation factor viia recombinant human—KitIntravenousLaboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)71127-200071127-2000-01
Sevenfactcoagulation factor viia recombinant human—KitIntravenousLaboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)71127-100071127-1000-01

Other NDCs under BLA 125641

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125641
ProductStrengthForm · routeLabelerProduct NDC
Sevenfactcoagulation factor viia recombinant human—KitIntravenousLaboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)71127-1000
Sevenfactcoagulation factor viia recombinant human—KitIntravenousLaboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)71127-2000

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in