Adalimumab-adbm NDC 0597-0585

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0585Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0585Add 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
0597-0585-89	00597058589	2 KIT in 1 CARTON (0597-0585-89) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0580-37) / .2 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKETMarketed from Oct 1, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Adalimumab-adbm
Generic name (nonproprietary): adalimumab-adbm
Dosage form: Kit
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761058
Marketing start: Oct 1, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 0597-0585_0d5e7bae-4147-49a4-8dd6-7763e9402614SPL ID 0d5e7bae-4147-49a4-8dd6-7763e9402614SPL set ID 62f39a7c-00df-4519-a8d4-39bbd0a649edRxCUI 797544, 2640883, 2640891, 2640893, 2640895, 2640900, 2640902, 2680743, 2680748, 2680756, 2680759

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

N400597058589 followed by a unit qualifier and the quantity

Package 00597-0585-89. 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 Nov 12, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 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 rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondyliti…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761058

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

FDA NDC Directory listings under BLA 761058
Product	Strength	Form · route	Labeler	Product NDC
Cyltezoadalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0400
Cyltezoadalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0405
Cyltezoadalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0485
Adalimumab-adbm	—	Kit	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-146
Adalimumab-adbm	—	Kit	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-144
Adalimumab-adbm	—	Kit	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-150
Adalimumab-adbm	—	Kit	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-148
Cyltezoadalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0495
Adalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0545
Adalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0555
Adalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0565
Adalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0575
Adalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0595
Cyltezoadalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0370
Cyltezoadalimumab-adbm	—	Kit	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0375