ogivri

Generic: trastuzumab-dkst

Labeler: biocon biologics inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ogivri
Generic Name trastuzumab-dkst
Labeler biocon biologics inc.
Dosage Form KIT
Manufacturer
Biocon Biologics Inc.

Identifiers & Regulatory

Product NDC 83257-004
Product ID 83257-004_ef07d382-d369-dfad-1491-3a4cc3b57d01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761074
Listing Expiration 2026-12-31
Marketing Start 2023-10-01

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 83257004
Hyphenated Format 83257-004

Supplemental Identifiers

RxCUI
2179753 2179758 2179760 2179763
UPC
0383257001113
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 ogivri (source: ndc)
Generic Name trastuzumab-dkst (source: ndc)
Application Number BLA761074 (source: ndc)
Routes
intravenous
source: label

Resolved Composition

Strengths
  • 150 mg
  • 420 mg
  • 20 ml
  • 1.1 %
source: label
Packaging
  • 1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11)
source: ndc

Packages (1)

83257-004-12 1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

OGIVRI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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 KIT in 1 CARTON (83257-004-12)  *  20 mL in 1 VIAL, MULTI-DOSE (83257-003-11)  *  20 mL in 1 VIAL (83257-002-11)", "package_ndc": "83257-004-12", "marketing_start_date": "20231001"}], "brand_name": "OGIVRI", "product_id": "83257-004_ef07d382-d369-dfad-1491-3a4cc3b57d01", "dosage_form": "KIT", "product_ndc": "83257-004", "generic_name": "trastuzumab-dkst", "labeler_name": "Biocon Biologics Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OGIVRI", "application_number": "BLA761074", "marketing_category": "BLA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}