NDC codes

FDA NDC Directory
Product NDC (as listed)73604-914Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73604-0914Add 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
73604-914-01736040914011 VIAL, SINGLE-USE in 1 CARTON (73604-914-01) / 2 mL in 1 VIAL, SINGLE-USEMarketed from Jun 18, 2021
73604-914-04736040914044 VIAL, SINGLE-USE in 1 CARTON (73604-914-04) / 2 mL in 1 VIAL, SINGLE-USEMarketed from Mar 24, 2008

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)
Arcalyst
Generic name (nonproprietary)
rilonacept
Active ingredients
Rilonacept — 160 mg/2mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Subcutaneous
Labeler
Kiniksa Pharmaceuticals (UK), Ltd.NDC labeler code 73604
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 125249
Marketing start
Listing expires
Identifiers
Product ID 73604-914_11e22c54-9b9a-4f9f-8680-cb7327511a23SPL ID 11e22c54-9b9a-4f9f-8680-cb7327511a23SPL set ID ad965f38-dd22-4607-a673-2fb92f3b527aRxCUI 763453, 763457UNII 8K80YB5GMG

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

N473604091401 followed by a unit qualifier and the quantity

Package 73604-0914-01. 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 .

Indications (excerpt from the label)

ARCALYST (rilonacept) is an interleukin-1 blocker indicated for: Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older ( 1.1 , 14.1 ) Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more ( 1.2 , 14.2 ) Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older ( 1.3 , 14.3 ) 1.1 Cryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome ARCALYST ® (rilonacept) is a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 73604-914

What is NDC 73604-914?
73604-914 is the product NDC for Arcalyst (rilonacept), Rilonacept 160 mg/2mL injection, powder, lyophilized, for solution, listed with the FDA by Kiniksa Pharmaceuticals (UK), Ltd.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Arcalyst (Rilonacept).
What is the active ingredient?
Rilonacept.
Who is the labeler?
Kiniksa Pharmaceuticals (UK), Ltd., NDC labeler code 73604. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Arcalyst?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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