FDA.reportPublic FDA data

HERZUMA

Product NDC
63459-303
Requested package NDC
63459-303-43
11-digit product format
634590303
Labeler code
63459
Product ID
63459-303_49f6182a-5e0f-45ea-8a0f-b774ef28a98f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRASTUZUMAB
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Cephalon, Inc.
Application
BLA761091
Marketing category
BLA
Marketing start
2020-03-16
Substance
TRASTUZUMAB
Active strength
150 mg/7.15mL
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
HERZUMA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRASTUZUMAB150 mg/7.15mL

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
2107053Internal RxNorm lookup
2107058Internal RxNorm lookup
2169359Internal RxNorm lookup
2169362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae71c003-883a-4cd8-ad50-e8cc9a54e971Available 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
63459-303-43HERZUMA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,114
63459-303-43HERZUMA20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63459-303-43EA - Each63459-303c3c45367-9418-4e54-b5b1-b318056006cb12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63459-303HERZUMA (TRASTUZUMAB) KIT HERZUMA (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INC.]13Current NDC, Legacy NDC, 2 package rows20250419_ae71c003-883a-4cd8-ad50-e8cc9a54e971.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
HERZUMATRASTUZUMABCephalon, Inc.ae71c003-883a-4cd8-ad50-e8cc9a54e9712025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761091
ndc (package): 63459-303-43
ndc (product): 63459-303
ndc11 (package): 63459030343

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761091Herzumatrastuzumab-pkrb351(k) BiosimilarRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2169362Herzuma 150 MG InjectionPSNae71c003-883a-4cd8-ad50-e8cc9a54e97114
2107058Herzuma 420 MG in 20 ML Injectable SolutionPSNae71c003-883a-4cd8-ad50-e8cc9a54e97114
2169359trastuzumab-pkrb 150 MG InjectionPSNae71c003-883a-4cd8-ad50-e8cc9a54e97114
2107053trastuzumab-pkrb 420 MG in 20 ML Injectable SolutionPSNae71c003-883a-4cd8-ad50-e8cc9a54e97114
2169362trastuzumab-pkrb 150 MG Injection [Herzuma]SBDae71c003-883a-4cd8-ad50-e8cc9a54e97114
2107058trastuzumab-pkrb 21 MG/ML Injectable Solution [Herzuma]SBDae71c003-883a-4cd8-ad50-e8cc9a54e97114
2169359trastuzumab-pkrb 150 MG InjectionSCDae71c003-883a-4cd8-ad50-e8cc9a54e97114
2107053trastuzumab-pkrb 21 MG/ML Injectable SolutionSCDae71c003-883a-4cd8-ad50-e8cc9a54e97114
2169362Herzuma 150 MG InjectionSYae71c003-883a-4cd8-ad50-e8cc9a54e97114
2107058Herzuma 21 MG/ML Injectable SolutionSYae71c003-883a-4cd8-ad50-e8cc9a54e97114
2107058Herzuma 420 MG per 20 ML Injectable SolutionSYae71c003-883a-4cd8-ad50-e8cc9a54e97114
2107053trastuzumab-pkrb 420 MG per 20 ML Injectable SolutionSYae71c003-883a-4cd8-ad50-e8cc9a54e97114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63459-303-43634590303431 VIAL, SINGLE-DOSE in 1 CARTON (63459-303-43) / 20 mL in 1 VIAL, SINGLE-DOSE2020-03-160000-00-00NoNoCurrent