Prescription drug · BLA

Tofidence (Tocilizumab) NDC 64406-024

Tocilizumab 20 mg/mL · Injection · Intravenous · Biogen MA Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)64406-024Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64406-0024Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
64406-024-01644060024011 VIAL, SINGLE-USE in 1 CARTON (64406-024-01) / 20 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 64406-024_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.

How CPT relates to drug billing

NDC on a medical claim

N464406002401 followed by a unit qualifier and the quantity

Package 64406-0024-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 64406-024

What is NDC 64406-024?
64406-024 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tofidence NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TofidencetocilizumabTocilizumab 80 mg/4mLInjectionIntravenousOrganon LLC78206-20078206-0200-01
TofidencetocilizumabTocilizumab 200 mg/10mLInjectionIntravenousOrganon LLC78206-20178206-0201-01
TofidencetocilizumabTocilizumab 400 mg/20mLInjectionIntravenousOrganon LLC78206-20278206-0202-01
TofidencetocilizumabTocilizumab 20 mg/mLInjectionIntravenousBiogen MA Inc64406-02264406-0022-01
TofidencetocilizumabTocilizumab 20 mg/mLInjectionIntravenousBiogen MA Inc64406-02364406-0023-01

Other NDCs under BLA 761354

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761354
ProductStrengthForm · routeLabelerProduct NDC
TofidencetocilizumabTocilizumab 80 mg/4mLInjectionIntravenousOrganon LLC78206-200
TofidencetocilizumabTocilizumab 200 mg/10mLInjectionIntravenousOrganon LLC78206-201
TofidencetocilizumabTocilizumab 400 mg/20mLInjectionIntravenousOrganon LLC78206-202
TofidencetocilizumabTocilizumab 20 mg/mLInjectionIntravenousBiogen MA Inc64406-022
TofidencetocilizumabTocilizumab 20 mg/mLInjectionIntravenousBiogen MA Inc64406-023

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Tofidence NDC 64406-024 | National Drug Code | Med-Code