Home NDC 67457-847 OGIVRI
Product NDC 67457-847
11-digit product format 674570847
Labeler code 67457
Product ID 67457-847_b57e61b9-04b7-4d8b-b7c2-be56a060421b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trastuzumab
Dosage form KIT
Labeler Mylan Institutional LLC
Application BLA761074
Marketing category BLA
Marketing start 2019-11-29
Marketing end 2027-04-30
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base OGIVRI DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67457-845-50 OGIVRI 20 mL in 1 VIAL, MULTI-DOSE INJECTION, POWDER, LYOPHILIZED, 20 mL 420 mg in 20mL 15 67457-847-44 OGIVRI 1 in 1 CARTON KIT 1 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-847 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 2026-06-26 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 2026-08-01
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 67457-845-50 67457084550 20 mL in 1 VIAL, MULTI-DOSE 20 ml Historical 67457-847-44 67457084744 1 KIT in 1 CARTON (67457-847-44) * 20 mL in 1 VIAL, MULTI-DOSE (67457-845-50) * 20 mL in 1 VIAL (67457-846-20) 1 kit 2019-11-29 2027-04-30 No No Current