Prescription drug · BLA
Kineret (Anakinra) NDC 66658-234
Anakinra 100 mg/.67mL · Injection, Solution · Subcutaneous · Swedish Orphan Biovitrum AB (publ)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66658-234-07 | 66658023407 | 7 SYRINGE, GLASS in 1 CARTON (66658-234-07) / .67 mL in 1 SYRINGE, GLASSMarketed from Dec 15, 2009 | |
| 66658-234-28 | 66658023428 | 4 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.
- NDC on a medical claim
N466658023407followed by a unit qualifier and the quantityPackage 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.
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.