Prescription drug · BLA
Bimzelx (Bimekizumab) NDC 50474-783
Bimekizumab 320 mg/2mL · Injection, Solution · Subcutaneous · UCB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50474-783-78 | 50474078378 | 1 SYRINGE, GLASS in 1 CARTON (50474-783-78) / 2 mL in 1 SYRINGE, GLASSMarketed from Dec 5, 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)
- Bimzelx
- Generic name (nonproprietary)
- bimekizumab
- Active ingredients
- Bimekizumab — 320 mg/2mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- UCB, Inc.NDC labeler code 50474
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761151
- Marketing start
- Listing expires
- Identifiers
- Product ID 50474-783_37b310bd-f6a0-9d4e-e063-6294a90a889dSPL ID 37b310bd-f6a0-9d4e-e063-6294a90a889dSPL set ID 26b88358-871f-4c80-9d80-b2fb16477f81RxCUI 2668086, 2668093, 2668099, 2668103, 2699121, 2699122, 2699123, 2699124UNII 09495UIM6V
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N450474078378followed by a unit qualifier and the quantityPackage 50474-0783-78. 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 .
Indications (excerpt from the label)
BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Adults with active psoriatic arthritis (PsA) . ( 1.2 ) Adults with active non-radiographic axial spondyloarthritis ( nr-axSpA ) with objective signs of inflammation. ( 1.3 ) Adults with active ankylosing spondylitis ( AS ). ( 1.4 ) Adults with moderate to severe hidradenitis suppurativa (HS) . ( 1.5 ) 1.1 Plaque Psoriasis BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis BI…
Excerpt only. Read the full label for complete information.
About NDC 50474-783
- What is NDC 50474-783?
- 50474-783 is the product NDC for Bimzelx (bimekizumab), Bimekizumab 320 mg/2mL injection, solution, listed with the FDA by UCB, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bimzelx (Bimekizumab).
- What is the active ingredient?
- Bimekizumab.
- Who is the labeler?
- UCB, Inc., NDC labeler code 50474. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bimzelx?
- 3 other product NDCs are listed under this name. See all Bimzelx NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bimzelx products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bimzelxbimekizumab | Bimekizumab 320 mg/2mL | Injection, SolutionSubcutaneous | UCB, Inc. | 50474-782 | 50474-0782-8450474-0782-86 |
| Bimzelxbimekizumab | Bimekizumab 160 mg/mL | Injection, SolutionSubcutaneous | UCB, Inc. | 50474-780 | 50474-0780-7850474-0780-79 |
| Bimzelxbimekizumab | Bimekizumab 160 mg/mL | Injection, SolutionSubcutaneous | UCB, Inc. | 50474-781 | 50474-0781-8450474-0781-8550474-0781-86+1 more |
Other NDCs under BLA 761151
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 |
|---|---|---|---|---|
| Bimzelxbimekizumab | Bimekizumab 160 mg/mL | Injection, SolutionSubcutaneous | UCB, Inc. | 50474-780 |
| Bimzelxbimekizumab | Bimekizumab 160 mg/mL | Injection, SolutionSubcutaneous | UCB, Inc. | 50474-781 |
| Bimzelxbimekizumab | Bimekizumab 320 mg/2mL | Injection, SolutionSubcutaneous | UCB, Inc. | 50474-782 |