Rituxan (rituximab) NDC 50242-053

NDC codes

FDA NDC Directory

Product NDC (as listed)50242-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50242-0053Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50242-053-06	50242005306	1 VIAL, SINGLE-USE in 1 CARTON (50242-053-06) / 50 mL in 1 VIAL, SINGLE-USEMarketed from Nov 26, 1997

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
Generic name (nonproprietary): rituximab
Active ingredients: Rituximab — 10 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Genentech, Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 103705
Marketing start: Nov 26, 1997
Listing expires: Dec 31, 2026
Other FDA classes: CD20-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 50242-053_3a716937-c2af-4bf9-976c-c34746b22ff0SPL ID 3a716937-c2af-4bf9-976c-c34746b22ff0SPL set ID b172773b-3905-4a1c-ad95-bab4b6126563RxCUI 1657862, 1657864, 1657867, 1657868UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N450242005306 followed by a unit qualifier and the quantity

Package 50242-0053-06. 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 Jan 6, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

RITUXAN 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 103705

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 103705
Product	Strength	Form · route	Labeler	Product NDC
Rituxanrituximab	Rituximab 10 mg/mL	Injection, SolutionIntravenous	Genentech, Inc.	50242-051