columvi

Generic: glofitamab

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

Drug Facts

Product Profile

Brand Name columvi
Generic Name glofitamab
Labeler genentech, inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

glofitamab 2.5 mg/2.5mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-125
Product ID 50242-125_5e794f49-9344-4145-82e3-c2f7f96988c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761309
Listing Expiration 2026-12-31
Marketing Start 2023-06-15

Pharmacologic Class

Established (EPC)
bispecific cd20-directed cd3 t cell engager [epc]
Mechanism of Action
cd20-directed antibody interactions [moa] cd3-directed antibody interactions [moa] cd3 receptor agonists [moa] cytochrome p450 inhibitors [moa]
Physiologic Effect
increased cytokine activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242125
Hyphenated Format 50242-125

Supplemental Identifiers

RxCUI
2639786 2639792 2639794 2639795
UNII
06P3KLK2J8
NUI
N0000194063 N0000175078 N0000175617 N0000175618 N0000009267 N0000182136

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 columvi (source: ndc)
Generic Name glofitamab (source: ndc)
Application Number BLA761309 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/2.5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

50242-125-01 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

glofitamab (2.5 mg/2.5mL)

Linked Drug Pages (1)

Columvi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5e794f49-9344-4145-82e3-c2f7f96988c5", "openfda": {"nui": ["N0000194063", "N0000175078", "N0000175617", "N0000175618", "N0000009267", "N0000182136"], "unii": ["06P3KLK2J8"], "rxcui": ["2639786", "2639792", "2639794", "2639795"], "spl_set_id": ["3516e753-f064-4d30-9bd5-e3f2e143f75d"], "pharm_class_pe": ["Increased Cytokine Activity [PE]"], "pharm_class_epc": ["Bispecific CD20-directed CD3 T Cell Engager [EPC]"], "pharm_class_moa": ["CD20-directed Antibody Interactions [MoA]", "CD3-directed Antibody Interactions [MoA]", "CD3 Receptor Agonists [MoA]", "Cytochrome P450 Inhibitors [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01)  / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50242-125-01", "marketing_start_date": "20230615"}], "brand_name": "Columvi", "product_id": "50242-125_5e794f49-9344-4145-82e3-c2f7f96988c5", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Bispecific CD20-directed CD3 T Cell Engager [EPC]", "CD20-directed Antibody Interactions [MoA]", "CD3 Receptor Agonists [MoA]", "CD3-directed Antibody Interactions [MoA]", "Cytochrome P450 Inhibitors [MoA]", "Increased Cytokine Activity [PE]"], "product_ndc": "50242-125", "generic_name": "Glofitamab", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Columvi", "active_ingredients": [{"name": "GLOFITAMAB", "strength": "2.5 mg/2.5mL"}], "application_number": "BLA761309", "marketing_category": "BLA", "marketing_start_date": "20230615", "listing_expiration_date": "20261231"}