gazyva

Generic: obinutuzumab

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

Drug Facts

Product Profile

Brand Name gazyva
Generic Name obinutuzumab
Labeler genentech, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

obinutuzumab 1000 mg/40mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-070
Product ID 50242-070_47afa519-4a05-4ac2-8604-437371837128
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125486
Listing Expiration 2026-12-31
Marketing Start 2013-11-01

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 50242070
Hyphenated Format 50242-070

Supplemental Identifiers

RxCUI
1442693 1442698
UNII
O43472U9X8
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 gazyva (source: ndc)
Generic Name obinutuzumab (source: ndc)
Application Number BLA125486 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1000 mg/40mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (50242-070-01) / 40 mL in 1 VIAL, SINGLE-USE
  • 1 VIAL, SINGLE-USE in 1 CARTON (50242-070-86) / 40 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

50242-070-01 1 VIAL, SINGLE-USE in 1 CARTON (50242-070-01) / 40 mL in 1 VIAL, SINGLE-USE 50242-070-86 1 VIAL, SINGLE-USE in 1 CARTON (50242-070-86) / 40 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

obinutuzumab (1000 mg/40mL)

Linked Drug Pages (1)

Gazyva ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "47afa519-4a05-4ac2-8604-437371837128", "openfda": {"nui": ["N0000175078", "N0000175657"], "unii": ["O43472U9X8"], "rxcui": ["1442693", "1442698"], "spl_set_id": ["df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda"], "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 (50242-070-01)  / 40 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-070-01", "marketing_start_date": "20131101"}, {"sample": true, "description": "1 VIAL, SINGLE-USE in 1 CARTON (50242-070-86)  / 40 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50242-070-86", "marketing_start_date": "20131104"}], "brand_name": "Gazyva", "product_id": "50242-070_47afa519-4a05-4ac2-8604-437371837128", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["CD20-directed Antibody Interactions [MoA]", "CD20-directed Cytolytic Antibody [EPC]"], "product_ndc": "50242-070", "generic_name": "obinutuzumab", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gazyva", "active_ingredients": [{"name": "OBINUTUZUMAB", "strength": "1000 mg/40mL"}], "application_number": "BLA125486", "marketing_category": "BLA", "marketing_start_date": "20131101", "listing_expiration_date": "20261231"}