FDA.reportPublic FDA data

OGIVRI

Product NDC
83257-003
11-digit product format
832570003
Labeler code
83257
Product ID
83257-003_ef07d382-d369-dfad-1491-3a4cc3b57d01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trastuzumab-dkst
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Biocon Biologics Inc.
Application
BLA761074
Marketing category
BLA
Marketing start
2023-10-01
Substance
TRASTUZUMAB
Active strength
420 mg/20mL
Pharmacologic classes
HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OGIVRI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRASTUZUMAB420 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP188ANX8CK
Rxcui2179753, 2179758, 2179760, 2179763

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
83257-003-01OGIVRI20 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,2014
83257-003-01OGIVRI1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,114
83257-003-11OGIVRI20 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,20 mL420 mg in 20mL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-003OGIVRI (TRASTUZUMAB-DKST) KIT OGIVRI (TRASTUZUMAB-DKST) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BIOCON BIOLOGICS INC.]14Current NDC, 2 package rows20241212_b6465b44-a6dd-f99c-d009-6851cf05169c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2179758OGIVRI 150 MG InjectionPSNb6465b44-a6dd-f99c-d009-6851cf05169c14
2179763OGIVRI 420 MG in 20 ML Injectable SolutionPSNb6465b44-a6dd-f99c-d009-6851cf05169c14
2179753trastuzumab-dkst 150 MG InjectionPSNb6465b44-a6dd-f99c-d009-6851cf05169c14
2179760trastuzumab-dkst 21 MG/ML Injectable SolutionPSNb6465b44-a6dd-f99c-d009-6851cf05169c14
2179758trastuzumab-dkst 150 MG Injection [Ogivri]SBDb6465b44-a6dd-f99c-d009-6851cf05169c14
2179763trastuzumab-dkst 21 MG/ML Injectable Solution [Ogivri]SBDb6465b44-a6dd-f99c-d009-6851cf05169c14
2179753trastuzumab-dkst 150 MG InjectionSCDb6465b44-a6dd-f99c-d009-6851cf05169c14
2179760trastuzumab-dkst 21 MG/ML Injectable SolutionSCDb6465b44-a6dd-f99c-d009-6851cf05169c14
2179758Ogivri 150 MG InjectionSYb6465b44-a6dd-f99c-d009-6851cf05169c14
2179763Ogivri 21 MG/ML Injectable SolutionSYb6465b44-a6dd-f99c-d009-6851cf05169c14
2179763Ogivri 420 MG per 20 ML Injectable SolutionSYb6465b44-a6dd-f99c-d009-6851cf05169c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
83257-003-018325700030120 mL in 1 VIAL, MULTI-DOSE20 mlHistorical
83257-003-118325700031120 mL in 1 VIAL, MULTI-DOSE20 mlHistorical