FDA.reportPublic FDA data

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OGIVRITRASTUZUMAB-DKSTBiocon Biologics Inc.b6465b44-a6dd-f99c-d009-6851cf05169c2024-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761074

Additional Listing Data#

Finished product
Yes
Brand name base
OGIVRI

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
9397f6d4-17a1-42b4-beda-fa2c0ea40c8cProduct name120190610
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-845-50OGIVRI20 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,20 mL420 mg in 20mL15
67457-847-44OGIVRI1 in 1 CARTONKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-847-44EA - Each67457-84739eec129-14bf-4442-9b0a-65c5b886e9b112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-847OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]15Current NDC, Legacy NDC, 2 package rows20240110_6b7938e6-14c7-4a65-9605-967542ecfb8f.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761074Ogivritrastuzumab-dkst351(k) BiosimilarRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2179758OGIVRI 150 MG InjectionPSN6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179763OGIVRI 420 MG in 20 ML Injectable SolutionPSN6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179753trastuzumab-dkst 150 MG InjectionPSN6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179760trastuzumab-dkst 21 MG/ML Injectable SolutionPSN6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179758trastuzumab-dkst 150 MG Injection [Ogivri]SBD6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179763trastuzumab-dkst 21 MG/ML Injectable Solution [Ogivri]SBD6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179753trastuzumab-dkst 150 MG InjectionSCD6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179760trastuzumab-dkst 21 MG/ML Injectable SolutionSCD6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179758Ogivri 150 MG InjectionSY6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179763Ogivri 21 MG/ML Injectable SolutionSY6b7938e6-14c7-4a65-9605-967542ecfb8f15
2179763Ogivri 420 MG per 20 ML Injectable SolutionSY6b7938e6-14c7-4a65-9605-967542ecfb8f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-845-506745708455020 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
67457-847-44674570847441 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 kit2019-11-292027-04-30NoNoCurrent