FDA.reportPublic FDA data

Ontruzant

Product NDC
78206-147
11-digit product format
782060147
Labeler code
78206
Product ID
78206-147_9b665849-a59e-4da6-ae51-36b3c885b85b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trastuzumab
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Organon LLC
Application
BLA761100
Marketing category
BLA
Marketing start
2021-06-01
Substance
TRASTUZUMAB
Active strength
150 mg/1
Pharmacologic classes
HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ontruzant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRASTUZUMAB150 mg/1

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
2289227Internal RxNorm lookup
2289232Internal RxNorm lookup
2289234Internal RxNorm lookup
2289237Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce2a2492-85e3-4b0a-872a-047f44e4203dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
9397f6d4-17a1-42b4-beda-fa2c0ea40c8cProduct name120190610
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-147-01Ontruzant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
78206-147-99Ontruzant1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-147-01EA - Each78206-1479dcf0daa-4ad8-4eb9-9e79-c2a02754dd8b12021-10-08
78206-147-99EA - Each78206-147b663553a-6498-4fc7-ae61-a6114133ee6412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-147ONTRUZANT (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ONTRUZANT KIT [ORGANON LLC]4Current NDC, Legacy NDC, 2 package rows20250316_ce2a2492-85e3-4b0a-872a-047f44e4203d.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
OntruzantTRASTUZUMABOrganon LLCce2a2492-85e3-4b0a-872a-047f44e4203d2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761100
ndc (product): 78206-147

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761100Ontruzanttrastuzumab-dttb351(k) BiosimilarRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2289232Ontruzant 150 MG InjectionPSNce2a2492-85e3-4b0a-872a-047f44e4203d6
2289237Ontruzant 420 MG in 20 ML Injectable SolutionPSNce2a2492-85e3-4b0a-872a-047f44e4203d6
2289227trastuzumab-dttb 150 MG InjectionPSNce2a2492-85e3-4b0a-872a-047f44e4203d6
2289234trastuzumab-dttb 420 MG in 20 ML Injectable SolutionPSNce2a2492-85e3-4b0a-872a-047f44e4203d6
2289232trastuzumab-dttb 150 MG Injection [Ontruzant]SBDce2a2492-85e3-4b0a-872a-047f44e4203d6
2289237trastuzumab-dttb 21 MG/ML Injectable Solution [Ontruzant]SBDce2a2492-85e3-4b0a-872a-047f44e4203d6
2289227trastuzumab-dttb 150 MG InjectionSCDce2a2492-85e3-4b0a-872a-047f44e4203d6
2289234trastuzumab-dttb 21 MG/ML Injectable SolutionSCDce2a2492-85e3-4b0a-872a-047f44e4203d6
2289232Ontruzant 150 MG InjectionSYce2a2492-85e3-4b0a-872a-047f44e4203d6
2289237Ontruzant 21 MG/ML Injectable SolutionSYce2a2492-85e3-4b0a-872a-047f44e4203d6
2289237Ontruzant 420 MG per 20 ML Injectable SolutionSYce2a2492-85e3-4b0a-872a-047f44e4203d6
2289234trastuzumab-dttb 420 MG per 20 ML Injectable SolutionSYce2a2492-85e3-4b0a-872a-047f44e4203d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78206-147-01782060147011 VIAL, SINGLE-DOSE in 1 CARTON (78206-147-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (78206-147-99) 2021-06-010000-00-00NoNoCurrent
78206-147-99782060147991 in 1 VIAL, SINGLE-DOSEHistorical