FDA.reportPublic FDA data

OGIVRI

Product NDC
67457-845
11-digit product format
674570845
Labeler code
67457
Product ID
67457-845_476fea90-ea21-4542-80eb-e3cf13653ad9
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
0000-00-00
Substance
TRASTUZUMAB
Active strength
420 mg/20mL
Pharmacologic classes
HER2/neu Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67457-845-202023-09-06C16284748780-1f386c64a-3e12-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OGIVRI safely and effectively. See full prescribing information for OGIVRI . OGIVRI ® (trastuzumab-dkst) for injection, for intravenous use Initial U.S. Approval: 2017 OGIVRI ® (trastuzumab-dkst) is biosimilar* to HERCEPTIN (trastuzumab).
67457-845-202023-02-01C16284748780-1f386c64a-3e12-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OGIVRI safely and effectively. See full prescribing information for OGIVRI . OGIVRI ® (trastuzumab-dkst) for injection, for intravenous use Initial U.S. Approval: 2017 OGIVRI ® (trastuzumab-dkst) is biosimilar* to HERCEPTIN (trastuzumab).

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-845OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]15Legacy NDC20240110_6b7938e6-14c7-4a65-9605-967542ecfb8f.zip

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 formatDescriptionUnitsStatus
67457-845-506745708455020 mL in 1 VIAL, MULTI-DOSE20 mlHistorical