Prescription drug · BLA
Cyltezo (Adalimumab-adbm) NDC 0597-0370
Kit · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0370-82 | 0059703708200597037082 | 2 KIT in 1 CARTON (0597-0370-82) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKETMarketed from Jul 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)
- Cyltezo
- Generic name (nonproprietary)
- adalimumab-adbm
- Dosage form
- Kit
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761058
- Marketing start
- Listing expires
- Identifiers
- Product ID 0597-0370_e7565b3d-b98e-46bb-906f-e821077068dcSPL ID e7565b3d-b98e-46bb-906f-e821077068dcSPL set ID 115ea79b-7209-7f19-b35d-36ec0828fbf5RxCUI 797544, 2640883, 2640889, 2640891, 2640892, 2640893, 2640894, 2640895, 2640898, 2640900, 2640901, 2640902, 2640903, 2680743, 2680746, 2680748, 2680750, 2680756, 2680757, 2680759, 2680760
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
N400597037082followed by a unit qualifier and the quantityPackage 00597-0370-82. 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)
CYLTEZO 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 spondylitis . ( 1.4 …
Excerpt only. Read the full label for complete information.
About NDC 0597-0370
- What is NDC 0597-0370?
- 0597-0370 is the product NDC for Cyltezo (adalimumab-adbm) kit, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyltezo (Adalimumab-adbm).
- Who is the labeler?
- Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cyltezo?
- 5 other product NDCs are listed under this name. See all Cyltezo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cyltezo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cyltezoadalimumab-adbm | — | Kit | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0485 | 00597-0485-20 |
| Cyltezoadalimumab-adbm | — | Kit | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0495 | 00597-0495-50 |
| Cyltezoadalimumab-adbm | — | Kit | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0375 | 00597-0375-97 |
| Cyltezoadalimumab-adbm | — | Kit | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0400 | 00597-0400-89 |
| Cyltezoadalimumab-adbm | — | Kit | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0405 | 00597-0405-80 |
Other NDCs under BLA 761058
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.