NDC codes

FDA NDC Directory
Product NDC (as listed)71104-922Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71104-0922Add 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
71104-922-01711040922011 KIT in 1 KIT (71104-922-01) * 5 mL in 1 VIAL (71104-954-09) * 5 mL in 1 VIAL (71104-045-01)Marketed from May 5, 2014

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)
Alprolix
Generic name (nonproprietary)
coagulation factor ix (recombinant), fc fusion protein
Dosage form
Kit
Labeler
Bioverativ Therapeutics Inc.NDC labeler code 71104
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125444
Marketing start
Listing expires
Identifiers
Product ID 71104-922_24887518-9870-451a-9db5-b03dc5571c19SPL ID 24887518-9870-451a-9db5-b03dc5571c19

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

N471104092201 followed by a unit qualifier and the quantity

Package 71104-0922-01. 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 71104-922

What is NDC 71104-922?
71104-922 is the product NDC for Alprolix 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?
Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein).
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 Alprolix?
5 other product NDCs are listed under this name. See all Alprolix 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 Alprolix NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-91171104-0911-01
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-93371104-0933-01
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-94471104-0944-01
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-96671104-0966-01
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-97771104-0977-01

Other NDCs under BLA 125444

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

FDA NDC Directory listings under BLA 125444
ProductStrengthForm · routeLabelerProduct NDC
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-911
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-933
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-944
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-966
Alprolixcoagulation factor ix (recombinant), fc fusion protein—KitBioverativ Therapeutics Inc.71104-977

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