Prescription drug · BLA
Rituxan Hycela (Rituximab and hyaluronidase) NDC 50242-108
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.NDC labeler code 50242
- 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_b81e9b67-233a-440d-aed6-95eaa6c9b4faSPL ID b81e9b67-233a-440d-aed6-95eaa6c9b4fa
- 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50242-108
- What is NDC 50242-108?
- 50242-108 is the product NDC for Rituxan Hycela, Rituximab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mL injection, solution, listed with the FDA by Genentech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rituxan Hycela (Rituximab and hyaluronidase).
- What is the active ingredient?
- Rituximab, Hyaluronidase (Human recombinant).
- Who is the labeler?
- Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rituxan Hycela?
- 1 other product NDC are listed under this name. See all Rituxan Hycela NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rituxan Hycela products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rituxan Hycelarituximab and hyaluronidase | Rituximab 120 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mL | Injection, SolutionSubcutaneous | Genentech, Inc. | 50242-109 | 50242-0109-01 |
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 |