Prescription drug · BLA
Riabni (Rituximab-arrx) NDC 55513-224
Rituximab 100 mg/10mL · Injection, Solution · Intravenous · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-224-01 | 5551302240155513022401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 6, 2021 | |
| 55513-224-21 | 5551302242155513022421 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-21) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 21, 2025 |
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)
- Riabni
- Generic name (nonproprietary)
- rituximab-arrx
- Active ingredients
- Rituximab — 100 mg/10mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Amgen, IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761140
- Marketing start
- Listing expires
- Other FDA classes
- CD20-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 55513-224_77661b91-57d2-42f2-98ff-371d8152284eSPL ID 77661b91-57d2-42f2-98ff-371d8152284e
- Pharmacologic class
- CD20-directed Cytolytic Antibody
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 codeMed-Code curated
J9312 — Injection, rituximab, 10 mg
Billing unit: 10 mg. Units on the claim = dose given ÷ 10 mg.
Rituximab biosimilars and rituximab with hyaluronidase have their own HCPCS codes.
- 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
N455513022401followed by a unit qualifier and the quantityPackage 55513-0224-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 55513-224
- What is NDC 55513-224?
- 55513-224 is the product NDC for Riabni (rituximab-arrx), Rituximab 100 mg/10mL injection, solution, listed with the FDA by Amgen, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Riabni (Rituximab-arrx).
- What is the active ingredient?
- Rituximab.
- Who is the labeler?
- Amgen, Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Riabni?
- 1 other product NDC are listed under this name. See all Riabni NDCs.
- Is there a related HCPCS / J-code?
- Yes: J9312, Injection, rituximab, 10 mg. See Billing references above.
Related NDCs: other Riabni products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Riabnirituximab-arrx | Rituximab 500 mg/50mL | Injection, SolutionIntravenous | Amgen, Inc | 55513-326 | 55513-0326-0155513-0326-21 |
Other NDCs under BLA 761140
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 |
|---|---|---|---|---|
| Riabnirituximab-arrx | Rituximab 500 mg/50mL | Injection, SolutionIntravenous | Amgen, Inc | 55513-326 |