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 | 55513022401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-224-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 6, 2021 | |
| 55513-224-21 | 55513022421 | 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, Inc
- 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_7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2SPL ID 7e0a4bc5-9a5f-4b66-ab41-a4417988ccc2SPL set ID da1c4de7-0e5b-4f72-97ec-7a8d368f085fRxCUI 2472327, 2472332, 2472335, 2472336UNII 4F4X42SYQ6
- 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large …
Excerpt only. Read the full label for complete information.
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 |
- Source
- FDA NDC Directory via openFDA; FDA SPL via openFDA and DailyMed; Med-Code HCPCS directory (curated)
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.