NDC 63459-104

Truxima

Rituximab-abbs

Truxima is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Inc.. The primary component is Rituximab.

• Product ID: 63459-104_0805ccb0-7bf3-4ecb-bbaa-febed8858040
• NDC: 63459-104
• Product Type: Human Prescription Drug
• Proprietary Name: Truxima
• Generic Name: Rituximab-abbs
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-05-04
• Marketing Category: BLA / BLA
• Application Number: BLA761088
• Labeler Name: Cephalon, Inc.
• Substance Name: RITUXIMAB
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 63459-104-50

1 VIAL, SINGLE-USE in 1 CARTON (63459-104-50) > 50 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2020-05-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63459-104-50 [63459010450]

Truxima INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761088
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-05-04

Drug Details

Active Ingredients

Ingredient	Strength
RITUXIMAB	10 mg/mL

OpenFDA Data

• SPL SET ID: 9af3ddc7-4217-417a-ac89-8704edc5bc44
• Manufacturer:
  • Cephalon, Inc.
• UNII:
  • 4F4X42SYQ6
• RxNorm Concept Unique ID - RxCUI:
  • 2105834
  • 2105826
  • 2105831
  • 2105835

Pharmacological Class

• CD20-directed Antibody Interactions [MoA]
• CD20-directed Cytolytic Antibody [EPC]

NDC Crossover Matching brand name "Truxima" or generic name "Rituximab-abbs"

NDC	Brand Name	Generic Name
63459-103	Truxima	rituximab-abbs
63459-104	Truxima	rituximab-abbs