NDC codes

FDA NDC Directory
Product NDC (as listed)69911-867Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69911-0867Add 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
69911-867-0269911086702699110867021 KIT in 1 CARTON (69911-867-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-877-01) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-85)Marketed from Mar 4, 2016

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)
Idelvion
Generic name (nonproprietary)
coagulation factor ix recombinant human
Dosage form
Kit
Labeler
CSL Behring Lengnau AGNDC labeler code 69911
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125582
Marketing start
Listing expires
Identifiers
Product ID 69911-867_fc29c907-a767-4a0e-b077-8c197e7ce8b3SPL ID fc29c907-a767-4a0e-b077-8c197e7ce8b3

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

N469911086702 followed by a unit qualifier and the quantity

Package 69911-0867-02. 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 69911-867

What is NDC 69911-867?
69911-867 is the product NDC for Idelvion (coagulation factor ix recombinant human) kit, listed with the FDA by CSL Behring Lengnau AG. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Idelvion (Coagulation Factor IX Recombinant Human).
Who is the labeler?
CSL Behring Lengnau AG, NDC labeler code 69911. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Idelvion?
4 other product NDCs are listed under this name. See all Idelvion 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 Idelvion NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Idelvioncoagulation factor ix recombinant human—KitCSL Behring Lengnau AG69911-86969911-0869-02
Idelvioncoagulation factor ix recombinant human—KitCSL Behring Lengnau AG69911-86469911-0864-02
Idelvioncoagulation factor ix recombinant human—KitCSL Behring Lengnau AG69911-86569911-0865-02
Idelvioncoagulation factor ix recombinant human—KitCSL Behring Lengnau AG69911-86669911-0866-02

Other NDCs under BLA 125582

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

FDA NDC Directory listings under BLA 125582
ProductStrengthForm · routeLabelerProduct NDC
Idelvioncoagulation factor ix recombinant human—KitCSL Behring Lengnau AG69911-864
Idelvioncoagulation factor ix recombinant human—KitCSL Behring Lengnau AG69911-865
Idelvioncoagulation factor ix recombinant human—KitCSL Behring Lengnau AG69911-866
Idelvioncoagulation factor ix recombinant human—KitCSL Behring Lengnau AG69911-869

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