Prescription drug · BLA
Rituxan Hycela NDC 50242-108
rituximab and hyaluronidase · Rituximab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mL · Injection, Solution · Subcutaneous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-108-01 | 50242010801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-01) / 11.7 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 22, 2017 | |
| 50242-108-86 | 50242010886 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-86) / 11.7 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 23, 2017 · Sample package |
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)
- Rituxan Hycela
- Generic name (nonproprietary)
- rituximab and hyaluronidase
- Active ingredients
- Rituximab — 120 mg/mLHyaluronidase (Human recombinant) — 2000 U/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Genentech, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761064
- Marketing start
- Listing expires
- Other FDA classes
- CD20-directed Antibody Interactions (Mechanism)Glycoside Hydrolases (Chemical structure)
- Identifiers
- Product ID 50242-108_e8a259ac-2a09-4026-823c-f23cbcba6a2bSPL ID e8a259ac-2a09-4026-823c-f23cbcba6a2bSPL set ID 3e5b7e82-f018-4eaf-ae78-d6145a906b20RxCUI 1927885, 1927890, 1927893, 1927894UNII 4F4X42SYQ6, 743QUY4VD8
- Pharmacologic class
- CD20-directed Cytolytic Antibody; Endoglycosidase
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
N450242010801followed by a unit qualifier and the quantityPackage 50242-0108-01. 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)
RITUXAN HYCELA is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult patients with: Follicular Lymphoma (FL) ( 1.1 ) Relapsed or refractory, follicular lymphoma as a single agent Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy Diffuse Large B-cell Lymphoma (DLBCL…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761064
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 |
|---|---|---|---|---|
| Rituxan Hycelarituximab and hyaluronidase | Rituximab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-109 |