NDC 50242-109

Rituxan Hycela

Rituximab And Hyaluronidase

Rituxan Hycela is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Rituximab; Hyaluronidase (human Recombinant).

• Product ID: 50242-109_1d917dd9-67b3-4f8c-8875-d3d383e06362
• NDC: 50242-109
• Product Type: Human Prescription Drug
• Proprietary Name: Rituxan Hycela
• Generic Name: Rituximab And Hyaluronidase
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-06-22
• Marketing Category: BLA / BLA
• Application Number: BLA761064
• Labeler Name: Genentech, Inc.
• Substance Name: RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)
• Active Ingredient Strength: 120 mg/mL; U/mL
• Pharm Classes: CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC],Endoglycosidase [EPC],Glycoside Hydrolases [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50242-109-01

1 VIAL, SINGLE-DOSE in 1 CARTON (50242-109-01) > 13.4 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-06-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-109-01 [50242010901]

Rituxan Hycela INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761064
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-06-22

Drug Details

Active Ingredients

Ingredient	Strength
RITUXIMAB	120 mg/mL

OpenFDA Data

• SPL SET ID: 3e5b7e82-f018-4eaf-ae78-d6145a906b20
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • 8KOG53Z5EM
  • 4F4X42SYQ6
• RxNorm Concept Unique ID - RxCUI:
  • 1927890
  • 1927893
  • 1927885
  • 1927894

Pharmacological Class

• CD20-directed Antibody Interactions [MoA]
• CD20-directed Cytolytic Antibody [EPC]
• Endoglycosidase [EPC]
• Glycoside Hydrolases [CS]

NDC Crossover Matching brand name "Rituxan Hycela" or generic name "Rituximab And Hyaluronidase"

NDC	Brand Name	Generic Name
50242-108	Rituxan Hycela	rituximab and hyaluronidase
50242-109	Rituxan Hycela	rituximab and hyaluronidase