Prescription drug · BLA
Ruxience (Rituximab-pvvr) NDC 0069-0249
Rituximab 500 mg/50mL · Injection, Solution · Intravenous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0249-01 | 00069024901 | 1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01) / 50 mL in 1 VIAL, SINGLE-USEMarketed from Jan 23, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Ruxience
- Generic name (nonproprietary)
- rituximab-pvvr
- Active ingredients
- Rituximab — 500 mg/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761103
- Marketing start
- Listing expires
- Other FDA classes
- CD20-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0069-0249_1f47d28b-1604-4e95-a668-46d81e4b5b27SPL ID 1f47d28b-1604-4e95-a668-46d81e4b5b27SPL set ID f941fc61-f7a3-4e4a-ab7c-87c1667fa05bRxCUI 2273512, 2273517, 2273520, 2273521UNII 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
N400069024901followed by a unit qualifier and the quantityPackage 00069-0249-01. 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)
RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: • Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). o Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. o 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. o 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. o Previously untreated di…
Excerpt only. Read the full label for complete information.
About NDC 0069-0249
- What is NDC 0069-0249?
- 0069-0249 is the product NDC for Ruxience (rituximab-pvvr), Rituximab 500 mg/50mL injection, solution, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ruxience (Rituximab-pvvr).
- What is the active ingredient?
- Rituximab.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ruxience?
- 1 other product NDC are listed under this name. See all Ruxience NDCs.
- Is there a related HCPCS / J-code?
- Yes: J9312, Injection, rituximab, 10 mg. See Billing references above.
Related NDCs: other Ruxience products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ruxiencerituximab-pvvr | Rituximab 100 mg/10mL | Injection, SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-0238 | 00069-0238-01 |
Other NDCs under BLA 761103
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 |
|---|---|---|---|---|
| Ruxiencerituximab-pvvr | Rituximab 100 mg/10mL | Injection, SolutionIntravenous | Pfizer Laboratories Div Pfizer Inc | 0069-0238 |