Package 83257-001-11

Brand: ogivri

Generic: trastuzumab-dkst
NDC Package

Package Facts

Identity

Package NDC 83257-001-11
Digits Only 8325700111
Product NDC 83257-001
Product ID 83257-001_ef07d382-d369-dfad-1491-3a4cc3b57d01
Description

1 VIAL in 1 CARTON (83257-001-11) / 15 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2023-10-01
Brand ogivri
Generic trastuzumab-dkst
Sample Package No

Linked Drug Pages (1)

OGIVRI ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ef07d382-d369-dfad-1491-3a4cc3b57d01", "openfda": {"nui": ["N0000175661", "N0000020008"], "upc": ["0383257001113"], "unii": ["P188ANX8CK"], "rxcui": ["2179753", "2179758", "2179760", "2179763"], "spl_set_id": ["b6465b44-a6dd-f99c-d009-6851cf05169c"], "pharm_class_epc": ["HER2/neu Receptor Antagonist [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]"], "manufacturer_name": ["Biocon Biologics Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (83257-001-11)  / 15 mL in 1 VIAL", "package_ndc": "83257-001-11", "marketing_start_date": "20231001"}], "brand_name": "OGIVRI", "product_id": "83257-001_ef07d382-d369-dfad-1491-3a4cc3b57d01", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["HER2/Neu/cerbB2 Antagonists [MoA]", "HER2/neu Receptor Antagonist [EPC]"], "product_ndc": "83257-001", "generic_name": "trastuzumab-dkst", "labeler_name": "Biocon Biologics Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OGIVRI", "active_ingredients": [{"name": "TRASTUZUMAB", "strength": "150 mg/7.4mL"}], "application_number": "BLA761074", "marketing_category": "BLA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}