FDA.reportPublic FDA data

HERZUMA

Product NDC
63459-303
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (product): 63459-303

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761091Herzumatrastuzumab-pkrb351(k) BiosimilarRx2026-06-01

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