rituxan

Generic: rituximab

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name rituxan
Generic Name rituximab
Labeler genentech, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rituximab 10 mg/mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-053
Product ID 50242-053_3a716937-c2af-4bf9-976c-c34746b22ff0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103705
Listing Expiration 2026-12-31
Marketing Start 1997-11-26

Pharmacologic Class

Established (EPC)
cd20-directed cytolytic antibody [epc]
Mechanism of Action
cd20-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242053
Hyphenated Format 50242-053

Supplemental Identifiers

RxCUI
1657862 1657864 1657867 1657868
UNII
4F4X42SYQ6
NUI
N0000175078 N0000175657

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rituxan (source: ndc)
Generic Name rituximab (source: ndc)
Application Number BLA103705 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (50242-053-06) / 50 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

50242-053-06 1 VIAL, SINGLE-USE in 1 CARTON (50242-053-06) / 50 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

rituximab (10 mg/mL)

Linked Drug Pages (1)

Rituxan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3a716937-c2af-4bf9-976c-c34746b22ff0", "openfda": {"nui": ["N0000175078", "N0000175657"], "unii": ["4F4X42SYQ6"], "rxcui": ["1657862", "1657864", "1657867", "1657868"], "spl_set_id": ["b172773b-3905-4a1c-ad95-bab4b6126563"], "pharm_class_epc": ["CD20-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (50242-053-06)  / 50 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-053-06", "marketing_start_date": "19971126"}], "brand_name": "Rituxan", "product_id": "50242-053_3a716937-c2af-4bf9-976c-c34746b22ff0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "50242-053", "generic_name": "rituximab", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rituxan", "active_ingredients": [{"name": "RITUXIMAB", "strength": "10 mg/mL"}], "application_number": "BLA103705", "marketing_category": "BLA", "marketing_start_date": "19971126", "listing_expiration_date": "20261231"}