Prescription drug · BLA
Adalimumab (Adalimumab-aaty) NDC 72606-040
Kit · CELLTRION USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72606-040-01 | 72606004001 | 1 KIT in 1 CARTON (72606-040-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Nov 30, 2023 | |
| 72606-040-02 | 72606004002 | 1 KIT in 1 CARTON (72606-040-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Nov 30, 2023 | |
| 72606-040-03 | 72606004003 | 2 KIT in 1 CARTON (72606-040-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Nov 30, 2023 | |
| 72606-040-04 | 72606004004 | 1 KIT in 1 CARTON (72606-040-04) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Nov 30, 2023 | |
| 72606-040-05 | 72606004005 | 2 KIT in 1 CARTON (72606-040-05) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Nov 30, 2023 | |
| 72606-040-06 | 72606004006 | 3 KIT in 1 CARTON (72606-040-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Nov 30, 2023 |
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)
- Adalimumab
- Generic name (nonproprietary)
- adalimumab-aaty
- Dosage form
- Kit
- Labeler
- CELLTRION USA, Inc.NDC labeler code 72606
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761219
- Marketing start
- Listing expires
- Identifiers
- Product ID 72606-040_4ba7057b-2495-42ba-9c35-95d87449259cSPL ID 4ba7057b-2495-42ba-9c35-95d87449259cSPL set ID c44365e9-d470-4e35-978d-8565a9e3471eRxCUI 797544, 2639651, 2639659, 2668483, 2668485, 2668487, 2668489
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
N472606004001followed by a unit qualifier and the quantityPackage 72606-0040-01. 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)
Adalimumab-aaty 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 r heumatoid 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 p soriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondyli…
Excerpt only. Read the full label for complete information.
About NDC 72606-040
- What is NDC 72606-040?
- 72606-040 is the product NDC for Adalimumab (adalimumab-aaty) kit, listed with the FDA by CELLTRION USA, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adalimumab (Adalimumab-aaty).
- Who is the labeler?
- CELLTRION USA, Inc., NDC labeler code 72606. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Adalimumab?
- 9 other product NDCs are listed under this name. See all Adalimumab NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Adalimumab products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Adalimumabadalimumab-adaz | Adalimumab 10 mg/.1mL | Injection, SolutionSubcutaneous | Sandoz Inc | 61314-391 | 61314-0391-64 |
| Adalimumabadalimumab-adaz | Adalimumab 80 mg/.8mL | Injection, SolutionSubcutaneous | Sandoz Inc | 61314-325 | 61314-0325-20 |
| Adalimumabadalimumab-adaz | Adalimumab 20 mg/.2mL | Injection, SolutionSubcutaneous | Sandoz Inc | 61314-332 | 61314-0332-64 |
| Adalimumabadalimumab-fkjp | — | Kit | Biocon Biologics Inc | 83257-020 | 83257-0020-42 |
| Adalimumabadalimumab-fkjp | — | Kit | Biocon Biologics Inc | 83257-021 | 83257-0021-42 |
| Adalimumabadalimumab-fkjp | — | Kit | Biocon Biologics Inc | 83257-022 | 83257-0022-32 |
| Adalimumabadalimumab-aaty | — | Kit | CELLTRION USA, Inc. | 72606-022 | 72606-0022-0172606-0022-0272606-0022-03+9 more |
| Adalimumabadalimumab-aaty | — | Kit | CELLTRION USA, Inc. | 72606-041 | 72606-0041-01 |
| Adalimumabadalimumab-adaz | Adalimumab 40 mg/.4mL | Injection, SolutionSubcutaneous | Sandoz Inc | 61314-327 | 61314-0327-2061314-0327-64 |
Other NDCs under BLA 761219
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 |
|---|---|---|---|---|
| Adalimumabadalimumab-aaty | — | Kit | CELLTRION USA, Inc. | 72606-022 |
| Yuflymaadalimumab-aaty | — | Kit | CELLTRION USA, Inc. | 72606-023 |
| Yuflymaadalimumab-aaty | — | Kit | CELLTRION USA, Inc. | 72606-030 |
| Adalimumabadalimumab-aaty | — | Kit | CELLTRION USA, Inc. | 72606-041 |