Idacio (adalimumab-aacf) NDC 65219-558

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-558Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0558Add 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 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, LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761255
Marketing start: Dec 9, 2024
Listing expires: Dec 31, 2026
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

N465219055808 followed by a unit qualifier and the quantity

Package 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 Oct 15, 2024. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761255

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

FDA NDC Directory listings under BLA 761255
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