FDA.reportPublic FDA data

OGIVRI

Product NDC
83257-001
11-digit product format
832570001
Labeler code
83257
Product ID
83257-001_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
150 mg/7.4mL
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
TRASTUZUMAB150 mg/7.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P188ANX8CKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2179753Internal RxNorm lookup
2179758Internal RxNorm lookup
2179760Internal RxNorm lookup
2179763Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6465b44-a6dd-f99c-d009-6851cf05169cAvailable on FDA.report

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
83257-001-11OGIVRI15 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1514
83257-001-11OGIVRI1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-001-11EA - Each83257-0012ebb8dd9-d1f2-4cd6-bac2-a4b2ecd7dd2012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-001OGIVRI (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

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
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
ndc (product): 83257-001

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761074Ogivritrastuzumab-dkst351(k) BiosimilarRx2026-07-01

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
83257-001-11832570001111 VIAL in 1 CARTON (83257-001-11) / 15 mL in 1 VIAL1 vial2023-10-01NoNoCurrent