NDC codes

FDA NDC Directory
Product NDC (as listed)71104-978Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71104-0978Add 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
71104-978-01711040978011 KIT in 1 KIT (71104-978-01) * 3 mL in 1 VIAL (71104-985-08) * 3 mL in 1 SYRINGE (71104-035-01)Marketed from Feb 22, 2023

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)
Altuviiio
Generic name (nonproprietary)
antihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl
Dosage form
Kit
Labeler
Bioverativ Therapeutics Inc.NDC labeler code 71104
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 125771
Marketing start
Listing expires
Identifiers
Product ID 71104-978_53f2b610-41b6-4485-ad9c-e7f445628ee5SPL ID 53f2b610-41b6-4485-ad9c-e7f445628ee5SPL set ID 01411972-df40-4ccf-88f0-d3220e5abda9RxCUI 2631088, 2631093

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

N471104097801 followed by a unit qualifier and the quantity

Package 71104-0978-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 71104-978

What is NDC 71104-978?
71104-978 is the product NDC for Altuviiio kit, listed with the FDA by Bioverativ Therapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Altuviiio (Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl).
Who is the labeler?
Bioverativ Therapeutics Inc., NDC labeler code 71104. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Altuviiio?
5 other product NDCs are listed under this name. See all Altuviiio 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 Altuviiio NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-97971104-0979-01
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-98171104-0981-01
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-98271104-0982-01
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-98371104-0983-01
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-98471104-0984-01

Other NDCs under BLA 125771

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

FDA NDC Directory listings under BLA 125771
ProductStrengthForm · routeLabelerProduct NDC
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-979
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-981
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-982
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-983
Altuviiioantihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl—KitBioverativ Therapeutics Inc.71104-984

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