Prescription drug · BLA
Tofidence (Tocilizumab) NDC 64406-023
Tocilizumab 20 mg/mL · Injection · Intravenous · Biogen MA Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64406-023-01 | 64406002301 | 1 VIAL, SINGLE-USE in 1 CARTON (64406-023-01) / 10 mL in 1 VIAL, SINGLE-USEMarketed from May 1, 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)
- Tofidence
- Generic name (nonproprietary)
- tocilizumab
- Active ingredients
- Tocilizumab — 20 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Biogen MA IncNDC labeler code 64406
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761354
- Marketing start
- Marketing end
- Other FDA classes
- Interleukin 6 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 64406-023_2edc5db5-3ecd-451e-bbdd-01fe8db1100bSPL ID 2edc5db5-3ecd-451e-bbdd-01fe8db1100bSPL set ID 00529b23-850a-42b9-a152-125a95b5242cRxCUI 2680287, 2680294, 2680296, 2680297, 2680298, 2680299UNII I031V2H011
- Pharmacologic class
- Interleukin-6 Receptor Antagonist
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
N464406002301followed by a unit qualifier and the quantityPackage 64406-0023-01. 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)
TOFIDENCE™ (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( 1.2 ) Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.3 ) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.4 ) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Coronavirus Disease 201…
Excerpt only. Read the full label for complete information.
About NDC 64406-023
- What is NDC 64406-023?
- 64406-023 is the product NDC for Tofidence (tocilizumab), Tocilizumab 20 mg/mL injection, listed with the FDA by Biogen MA Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tofidence (Tocilizumab).
- What is the active ingredient?
- Tocilizumab.
- Who is the labeler?
- Biogen MA Inc, NDC labeler code 64406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tofidence?
- 5 other product NDCs are listed under this name. See all Tofidence NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tofidence products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tofidencetocilizumab | Tocilizumab 80 mg/4mL | InjectionIntravenous | Organon LLC | 78206-200 | 78206-0200-01 |
| Tofidencetocilizumab | Tocilizumab 200 mg/10mL | InjectionIntravenous | Organon LLC | 78206-201 | 78206-0201-01 |
| Tofidencetocilizumab | Tocilizumab 400 mg/20mL | InjectionIntravenous | Organon LLC | 78206-202 | 78206-0202-01 |
| Tofidencetocilizumab | Tocilizumab 20 mg/mL | InjectionIntravenous | Biogen MA Inc | 64406-022 | 64406-0022-01 |
| Tofidencetocilizumab | Tocilizumab 20 mg/mL | InjectionIntravenous | Biogen MA Inc | 64406-024 | 64406-0024-01 |
Other NDCs under BLA 761354
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 |
|---|---|---|---|---|
| Tofidencetocilizumab | Tocilizumab 80 mg/4mL | InjectionIntravenous | Organon LLC | 78206-200 |
| Tofidencetocilizumab | Tocilizumab 200 mg/10mL | InjectionIntravenous | Organon LLC | 78206-201 |
| Tofidencetocilizumab | Tocilizumab 400 mg/20mL | InjectionIntravenous | Organon LLC | 78206-202 |
| Tofidencetocilizumab | Tocilizumab 20 mg/mL | InjectionIntravenous | Biogen MA Inc | 64406-022 |
| Tofidencetocilizumab | Tocilizumab 20 mg/mL | InjectionIntravenous | Biogen MA Inc | 64406-024 |