What is NDC 71127-1000?

71127-1000 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).

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sevenfact NDC 71127-1000 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71127-1000Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71127-1000Add 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 NDC	11-digit (billing)	Package	Copy
71127-1000-1	7112710000171127100001	1 KIT in 1 PACKAGE (71127-1000-1) * 1 mL in 1 VIAL, SINGLE-DOSE (71127-1100-1) * 1.1 mL in 1 SYRINGE (71127-1200-1)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: Dec 10, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 71127-1000_7a6bb0f4-e2de-4329-9cd8-b267f2c28b9eSPL ID 7a6bb0f4-e2de-4329-9cd8-b267f2c28b9e

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

N471127100001 followed by a unit qualifier and the quantity

Package 71127-1000-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 71127-1000

What is NDC 71127-1000?: 71127-1000 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
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.)	71127-5000	71127-5000-01

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
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.)	71127-2000
Sevenfactcoagulation factor viia recombinant human	—	KitIntravenous	Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)	71127-5000