Prescription drug · BLA
Idacio (Adalimumab-aacf) NDC 65219-558
Kit · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-558-08 | 65219055808 | 1 KIT in 1 CARTON (65219-558-08) * .8 mL in 1 VIAL, GLASS (65219-562-01) * 1 SWAB in 1 POUCH (65219-332-95)Marketed from Dec 9, 2024 |
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)
- Idacio
- Generic name (nonproprietary)
- adalimumab-aacf
- Dosage form
- Kit
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761255
- Marketing start
- Listing expires
- Identifiers
- Product ID 65219-558_08dbaffe-9d05-43cf-b24b-b44ade8685fcSPL ID 08dbaffe-9d05-43cf-b24b-b44ade8685fcSPL set ID 08dbaffe-9d05-43cf-b24b-b44ade8685fcRxCUI 797544, 2699315, 2699319
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
N465219055808followed by a unit qualifier and the quantityPackage 65219-0558-08. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
IDACIO is a tumor necrosis factor (TNF) blocker indicated for: • Rheumatoid Arthritis (RA) ( 1.1 ): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA . • Juvenile Idiopathic Arthritis (JIA) ( 1.2 ): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. • Psoriatic Arthritis (PsA) ( 1.3 ): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. • Ankylosing Spondylitis (AS) ( 1.4 ): reducing sign…
Excerpt only. Read the full label for complete information.
About NDC 65219-558
- What is NDC 65219-558?
- 65219-558 is the product NDC for Idacio (adalimumab-aacf) kit, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Idacio (Adalimumab-aacf).
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Idacio?
- 1 other product NDC are listed under this name. See all Idacio NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Idacio products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Idacioadalimumab-aacf | — | KitSubcutaneous | Fresenius Kabi USA, LLC | 65219-554 | 65219-0554-2865219-0554-38 |
Other NDCs under BLA 761255
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Idacioadalimumab-aacf | — | KitSubcutaneous | Fresenius Kabi USA, LLC | 65219-554 |
| Adalimumab-aacfadalimumab | — | KitSubcutaneous | Fresenius Kabi USA, LLC | 65219-612 |
| Adalimumab-aacfadalimumab | — | KitSubcutaneous | Fresenius Kabi USA, LLC | 65219-620 |