truxima

Generic: rituximab-abbs

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

Drug Facts

Product Profile

Brand Name truxima
Generic Name rituximab-abbs
Labeler cephalon, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rituximab 10 mg/mL

Manufacturer
Cephalon, Inc.

Identifiers & Regulatory

Product NDC 63459-103
Product ID 63459-103_de5d8106-44b8-4510-9129-f6a163c5231e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761088
Listing Expiration 2026-12-31
Marketing Start 2020-05-04

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 63459103
Hyphenated Format 63459-103

Supplemental Identifiers

RxCUI
2105826 2105831 2105834 2105835
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 truxima (source: ndc)
Generic Name rituximab-abbs (source: ndc)
Application Number BLA761088 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (63459-103-10) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

63459-103-10 1 VIAL, SINGLE-USE in 1 CARTON (63459-103-10) / 10 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

rituximab (10 mg/mL)

Linked Drug Pages (1)

Truxima ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "de5d8106-44b8-4510-9129-f6a163c5231e", "openfda": {"nui": ["N0000175078", "N0000175657"], "unii": ["4F4X42SYQ6"], "rxcui": ["2105826", "2105831", "2105834", "2105835"], "spl_set_id": ["9af3ddc7-4217-417a-ac89-8704edc5bc44"], "pharm_class_epc": ["CD20-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Cephalon, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (63459-103-10)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "63459-103-10", "marketing_start_date": "20200504"}], "brand_name": "Truxima", "product_id": "63459-103_de5d8106-44b8-4510-9129-f6a163c5231e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "63459-103", "generic_name": "rituximab-abbs", "labeler_name": "Cephalon, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Truxima", "active_ingredients": [{"name": "RITUXIMAB", "strength": "10 mg/mL"}], "application_number": "BLA761088", "marketing_category": "BLA", "marketing_start_date": "20200504", "listing_expiration_date": "20261231"}