NDC codes

FDA NDC Directory
Product NDC (as listed)66658-234Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66658-0234Add 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
66658-234-07666580234077 SYRINGE, GLASS in 1 CARTON (66658-234-07) / .67 mL in 1 SYRINGE, GLASSMarketed from Dec 15, 2009
66658-234-28666580234284 CARTON in 1 CASE (66658-234-28) / 7 SYRINGE, GLASS in 1 CARTON / .67 mL in 1 SYRINGE, GLASSMarketed from Dec 15, 2009

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)
Kineret
Generic name (nonproprietary)
anakinra
Active ingredients
Anakinra — 100 mg/.67mL
Dosage form
Injection, Solution
Route
Subcutaneous
Labeler
Swedish Orphan Biovitrum AB (publ)NDC labeler code 66658
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 103950
Marketing start
Listing expires
Other FDA classes
Interleukin 1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 66658-234_d1acb9d5-9241-4aeb-b3e7-f05dbc8c15a2SPL ID d1acb9d5-9241-4aeb-b3e7-f05dbc8c15a2SPL set ID d9d74915-6606-4570-9c52-c4001d3177deRxCUI 727711, 727714UNII 9013DUQ28K
Pharmacologic class
Interleukin-1 Receptor Antagonist

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

N466658023407 followed by a unit qualifier and the quantity

Package 66658-0234-07. 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)

KINERET is an interleukin-1 receptor antagonist indicated for: Rheumatoid Arthritis (RA) Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) ( 1.1 ) Cryopyrin-Associated Periodic Syndromes (CAPS) Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) ( 1.2 ) Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) ( 1.3 ) 1.1 Active Rheumatoid Arthritis KINERET is indicated for the reduction in signs and symptoms and slowi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66658-234

What is NDC 66658-234?
66658-234 is the product NDC for Kineret (anakinra), Anakinra 100 mg/.67mL injection, solution, listed with the FDA by Swedish Orphan Biovitrum AB (publ). It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Kineret (Anakinra).
What is the active ingredient?
Anakinra.
Who is the labeler?
Swedish Orphan Biovitrum AB (publ), NDC labeler code 66658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Kineret?
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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