ontruzant

Generic: ontruzant

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ontruzant
Generic Name ontruzant
Labeler organon llc
Dosage Form KIT
Routes
INTRAVENOUS
Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-148
Product ID 78206-148_a1dc858f-6aa7-4a25-a7bd-15a05aa4115c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761100
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Established (EPC)
her2/neu receptor antagonist [epc]
Mechanism of Action
her2/neu/cerbb2 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206148
Hyphenated Format 78206-148

Supplemental Identifiers

RxCUI
2289227 2289232 2289234 2289237
UPC
0378206147011
UNII
P188ANX8CK
NUI
N0000175661 N0000020008

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 ontruzant (source: ndc)
Generic Name ontruzant (source: ndc)
Application Number BLA761100 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg
  • 420 mg
  • 20 ml
  • 1.1 %
source: label
Packaging
  • 1 KIT in 1 CARTON (78206-148-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (78206-191-99) * 1 INJECTION, SOLUTION in 1 VIAL (78206-149-89)
source: ndc

Packages (1)

78206-148-01 1 KIT in 1 CARTON (78206-148-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (78206-191-99) * 1 INJECTION, SOLUTION in 1 VIAL (78206-149-89)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Ontruzant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a1dc858f-6aa7-4a25-a7bd-15a05aa4115c", "openfda": {"nui": ["N0000175661", "N0000020008"], "upc": ["0378206147011"], "unii": ["P188ANX8CK"], "rxcui": ["2289227", "2289232", "2289234", "2289237"], "spl_set_id": ["ce2a2492-85e3-4b0a-872a-047f44e4203d"], "pharm_class_epc": ["HER2/neu Receptor Antagonist [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (78206-148-01)  *  1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (78206-191-99)  *  1 INJECTION, SOLUTION in 1 VIAL (78206-149-89)", "package_ndc": "78206-148-01", "marketing_start_date": "20210601"}], "brand_name": "Ontruzant", "product_id": "78206-148_a1dc858f-6aa7-4a25-a7bd-15a05aa4115c", "dosage_form": "KIT", "product_ndc": "78206-148", "generic_name": "Ontruzant", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ontruzant", "application_number": "BLA761100", "marketing_category": "BLA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}