rituxan hycela

Generic: rituximab and hyaluronidase

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

Drug Facts

Product Profile

Brand Name rituxan hycela
Generic Name rituximab and hyaluronidase
Labeler genentech, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

hyaluronidase (human recombinant) 2000 U/mL, rituximab 120 mg/mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-108
Product ID 50242-108_e8a259ac-2a09-4026-823c-f23cbcba6a2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761064
Listing Expiration 2026-12-31
Marketing Start 2017-06-22

Pharmacologic Class

Established (EPC)
cd20-directed cytolytic antibody [epc] endoglycosidase [epc]
Mechanism of Action
cd20-directed antibody interactions [moa]
Chemical Structure
glycoside hydrolases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242108
Hyphenated Format 50242-108

Supplemental Identifiers

RxCUI
1927885 1927890 1927893 1927894
UNII
4F4X42SYQ6 743QUY4VD8
NUI
N0000175078 N0000175657 N0000175531 M0009499

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 hycela (source: ndc)
Generic Name rituximab and hyaluronidase (source: ndc)
Application Number BLA761064 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2000 U/mL
  • 120 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-01) / 11.7 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-86) / 11.7 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

50242-108-01 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-01) / 11.7 mL in 1 VIAL, SINGLE-DOSE 50242-108-86 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-86) / 11.7 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

hyaluronidase (human recombinant) (2000 U/mL) rituximab (120 mg/mL)

Linked Drug Pages (1)

Rituxan Hycela ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "e8a259ac-2a09-4026-823c-f23cbcba6a2b", "openfda": {"nui": ["N0000175078", "N0000175657", "N0000175531", "M0009499"], "unii": ["4F4X42SYQ6", "743QUY4VD8"], "rxcui": ["1927885", "1927890", "1927893", "1927894"], "spl_set_id": ["3e5b7e82-f018-4eaf-ae78-d6145a906b20"], "pharm_class_cs": ["Glycoside Hydrolases [CS]"], "pharm_class_epc": ["CD20-directed Cytolytic Antibody [EPC]", "Endoglycosidase [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-DOSE in 1 CARTON (50242-108-01)  / 11.7 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50242-108-01", "marketing_start_date": "20170622"}, {"sample": true, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-86)  / 11.7 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50242-108-86", "marketing_start_date": "20170623"}], "brand_name": "Rituxan Hycela", "product_id": "50242-108_e8a259ac-2a09-4026-823c-f23cbcba6a2b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]", "Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]"], "product_ndc": "50242-108", "generic_name": "rituximab and hyaluronidase", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rituxan Hycela", "active_ingredients": [{"name": "HYALURONIDASE (HUMAN RECOMBINANT)", "strength": "2000 U/mL"}, {"name": "RITUXIMAB", "strength": "120 mg/mL"}], "application_number": "BLA761064", "marketing_category": "BLA", "marketing_start_date": "20170622", "listing_expiration_date": "20261231"}