Prescription drug · BLA
Truxima (Rituximab-abbs) NDC 63459-103
Rituximab 10 mg/mL · Injection, Solution · Intravenous · Cephalon, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63459-103-10 | 63459010310 | 1 VIAL, SINGLE-USE in 1 CARTON (63459-103-10) / 10 mL in 1 VIAL, SINGLE-USEMarketed from May 4, 2020 |
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)
- Truxima
- Generic name (nonproprietary)
- rituximab-abbs
- Active ingredients
- Rituximab — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Cephalon, Inc.NDC labeler code 63459
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761088
- Marketing start
- Listing expires
- Other FDA classes
- CD20-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 63459-103_a284d45e-6142-4bfa-b716-7f2b976ffb0bSPL ID a284d45e-6142-4bfa-b716-7f2b976ffb0bSPL set ID 9af3ddc7-4217-417a-ac89-8704edc5bc44RxCUI 2105826, 2105831, 2105834, 2105835UNII 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
N463459010310followed by a unit qualifier and the quantityPackage 63459-0103-10. 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)
TRUXIMA (rituximab-abbs) 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 untrea…
Excerpt only. Read the full label for complete information.
About NDC 63459-103
- What is NDC 63459-103?
- 63459-103 is the product NDC for Truxima (rituximab-abbs), Rituximab 10 mg/mL injection, solution, listed with the FDA by Cephalon, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Truxima (Rituximab-abbs).
- What is the active ingredient?
- Rituximab.
- Who is the labeler?
- Cephalon, Inc., NDC labeler code 63459. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Truxima?
- 1 other product NDC are listed under this name. See all Truxima NDCs.
- Is there a related HCPCS / J-code?
- Yes: J9312, Injection, rituximab, 10 mg. See Billing references above.
Related NDCs: other Truxima products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Truximarituximab-abbs | Rituximab 10 mg/mL | Injection, SolutionIntravenous | Cephalon, Inc. | 63459-104 | 63459-0104-50 |
Other NDCs under BLA 761088
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 |
|---|---|---|---|---|
| Truximarituximab-abbs | Rituximab 10 mg/mL | Injection, SolutionIntravenous | Cephalon, Inc. | 63459-104 |