Prescription drug · BLA
Adalimumab (Adalimumab-fkjp) NDC 83257-021
Kit · Biocon Biologics Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83257-021-42 | 8325700214283257002142 | 2 TRAY in 1 KIT (83257-021-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKETMarketed from Apr 15, 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)
- Adalimumab
- Generic name (nonproprietary)
- adalimumab-fkjp
- Dosage form
- Kit
- Labeler
- Biocon Biologics IncNDC labeler code 83257
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761154
- Marketing start
- Listing expires
- Identifiers
- Product ID 83257-021_39c67c8f-7fbd-a17a-1535-5d41ece68818SPL ID 39c67c8f-7fbd-a17a-1535-5d41ece68818SPL set ID 5cde907d-6747-0e62-db25-1718ee717fe7RxCUI 797544, 2640404, 2640412, 2640417
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
N483257002142followed by a unit qualifier and the quantityPackage 83257-0021-42. 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-fkjp 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. J uvenile 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. A nkylosing Spondylitis (AS) ( 1.4 ): reducing …
Excerpt only. Read the full label for complete information.
About NDC 83257-021
- What is NDC 83257-021?
- 83257-021 is the product NDC for Adalimumab (adalimumab-fkjp) kit, listed with the FDA by Biocon Biologics Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adalimumab (Adalimumab-fkjp).
- Who is the labeler?
- Biocon Biologics Inc, NDC labeler code 83257. 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 | 83257-022 | 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. | 72606-040 | 72606-0040-0172606-0040-0272606-0040-03+3 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 761154
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-fkjp | — | Kit | Biocon Biologics Inc | 83257-020 |
| Adalimumabadalimumab-fkjp | — | Kit | Biocon Biologics Inc | 83257-022 |
| Hulioadalimumab-fkjp | — | Kit | Biocon Biologics Inc | 83257-016 |
| Hulioadalimumab-fkjp | — | Kit | Biocon Biologics Inc | 83257-019 |