Prescription drug · BLA
Actemra (Tocilizumab) NDC 50242-137
Tocilizumab 400 mg/20mL · Injection, Solution, Concentrate · Intravenous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-137-01 | 50242013701 | 1 VIAL, SINGLE-USE in 1 BOX (50242-137-01) / 20 mL in 1 VIAL, SINGLE-USEMarketed from Jan 8, 2010 |
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)
- Actemra
- Generic name (nonproprietary)
- tocilizumab
- Active ingredients
- Tocilizumab — 400 mg/20mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125276
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin 6 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50242-137_7f1b03d3-e0e1-4d90-b588-bb8d3ecb154aSPL ID 7f1b03d3-e0e1-4d90-b588-bb8d3ecb154aSPL set ID 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13RxCUI 1441527, 1441530, 1657974, 1657976, 1657979, 1657980, 1657981, 1657982, 2106073, 2106075UNII 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
N450242013701followed by a unit qualifier and the quantityPackage 50242-0137-01. 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)
ACTEMRA ® (tocilizumab) 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. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) ( 1.3 ) Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.4 ) Patients 2 years of age and older with active p…
Excerpt only. Read the full label for complete information.
About NDC 50242-137
- What is NDC 50242-137?
- 50242-137 is the product NDC for Actemra (tocilizumab), Tocilizumab 400 mg/20mL injection, solution, concentrate, listed with the FDA by Genentech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Actemra (Tocilizumab).
- What is the active ingredient?
- Tocilizumab.
- Who is the labeler?
- Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Actemra?
- 3 other product NDCs are listed under this name. See all Actemra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Actemra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Actemratocilizumab | Tocilizumab 162 mg/.9mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-138 | 50242-0138-0150242-0138-86 |
| Actemratocilizumab | Tocilizumab 80 mg/4mL | Injection, Solution, ConcentrateIntravenous | Genentech, Inc. | 50242-135 | 50242-0135-01 |
| Actemratocilizumab | Tocilizumab 200 mg/10mL | Injection, Solution, ConcentrateIntravenous | Genentech, Inc. | 50242-136 | 50242-0136-01 |
Other NDCs under BLA 125276
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 |
|---|---|---|---|---|
| Actemratocilizumab | Tocilizumab 80 mg/4mL | Injection, Solution, ConcentrateIntravenous | Genentech, Inc. | 50242-135 |
| Actemratocilizumab | Tocilizumab 200 mg/10mL | Injection, Solution, ConcentrateIntravenous | Genentech, Inc. | 50242-136 |