Prescription drug · BLA
Humira (adalimumab) NDC 83457-124
Kit · Cordavis Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83457-124-02 | 83457012402 | 2 KIT in 1 CARTON (83457-124-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (83457-123-01) / .8 mL in 1 SYRINGE * 1 mL in 1 PACKET (83457-927-01)Marketed from Feb 14, 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)
- Humira
- Generic name (nonproprietary)
- adalimumab
- Dosage form
- Kit
- Labeler
- Cordavis Limited
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125057
- Marketing start
- Listing expires
- Identifiers
- Product ID 83457-124_5fe81b1a-cc31-444e-a0f1-1ea4f7334b89SPL ID 5fe81b1a-cc31-444e-a0f1-1ea4f7334b89SPL set ID 4977567e-3525-44ac-9ff5-f1e74b053950RxCUI 797544, 1726844, 1726846, 1872979, 1872980, 1921009, 1921010, 1921016, 1921017, 1921238, 1921240
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
N483457012402followed by a unit qualifier and the quantityPackage 83457-0124-02. 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)
HUMIRA 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 a rthritis . ( 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…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125057
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 |
|---|---|---|---|---|
| Humiraadalimumab | — | Kit | AbbVie Inc. | 0074-0817 |
| Humiraadalimumab | — | Kit | A-S Medication Solutions | 50090-4487 |
| Humiraadalimumab | — | Kit | AbbVie Inc. | 0074-0243 |
| Humiraadalimumab | — | Kit | AbbVie Inc. | 0074-2540 |
| Humiraadalimumab | — | Kit | AbbVie Inc. | 0074-0554 |
| Humiraadalimumab | — | Kit | AbbVie Inc. | 0074-0616 |
| Humiraadalimumab | — | Kit | AbbVie Inc. | 0074-3799 |
| Humiraadalimumab | — | Kit | AbbVie Inc. | 0074-0124 |
| Humiraadalimumab | — | Kit | AbbVie Inc. | 0074-4339 |
| Humiraadalimumab | — | Kit | AbbVie Inc. | 0074-1539 |
| Humiraadalimumab | — | Kit | Cordavis Limited | 83457-616 |
| Humiraadalimumab | — | Kit | Cordavis Limited | 83457-243 |
| Humiraadalimumab | — | Kit | Cordavis Limited | 83457-554 |
| Humiraadalimumab | — | Kit | Cordavis Limited | 83457-817 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.