Home NDC 83257-004-12 OGIVRI
Product NDC 83257-004
Requested package NDC 83257-004-12
11-digit product format 832570004
Labeler code 83257
Product ID 83257-004_ed1bbb0a-ad1a-6cb6-e955-e9ae2ce9c40f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trastuzumab-dkst
Dosage form KIT
Labeler Biocon Biologics Inc.
Application BLA761074
Marketing category BLA
Marketing start 2023-10-01
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base OGIVRI
Listing expiration 2027-12-31 Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P188ANX8CK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2179753 Internal RxNorm lookup 2179758 Internal RxNorm lookup 2179760 Internal RxNorm lookup 2179763 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83257-003-11 OGIVRI 20 mL in 1 VIAL, MULTI-DOSE INJECTION, POWDER, LYOPHILIZED, 20 mL 420 mg in 20mL 14 83257-004-12 OGIVRI 1 in 1 CARTON KIT 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83257-004 OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BIOCON BIOLOGICS INC.] 14 Current NDC, 2 package rows 20241212_b6465b44-a6dd-f99c-d009-6851cf05169c.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.
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 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83257-004-12 83257000412 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) 1 kit 2023-10-01 No No Current