Home NDC 67457-991 OGIVRI
Product NDC 67457-991
11-digit product format 674570991
Labeler code 67457
Product ID 67457-991_b57e61b9-04b7-4d8b-b7c2-be56a060421b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trastuzumab
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application BLA761074
Marketing category BLA
Marketing start 2019-11-29
Marketing end 2027-02-28
Substance TRASTUZUMAB
Active strength 150 mg/7.4mL
Pharmacologic classes HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base OGIVRI Active Ingredients# Ingredient, Strength table Ingredient Strength TRASTUZUMAB 150 mg/7.4mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67457-991-15 OGIVRI 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 15 67457-991-15 OGIVRI 15 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 15 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-991 OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 15 Current NDC, Legacy NDC, 2 package rows 20240110_6b7938e6-14c7-4a65-9605-967542ecfb8f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OGIVRI TRASTUZUMAB-DKST Biocon Biologics Inc. b6465b44-a6dd-f99c-d009-6851cf05169c 2024-11-30 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761074
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761074 Ogivri trastuzumab-dkst 351(k) Biosimilar Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67457-991-15 67457099115 1 VIAL in 1 CARTON (67457-991-15) / 15 mL in 1 VIAL 1 vial 2019-11-29 2027-02-28 No No Current