FDA.reportPublic FDA data

Herceptin

Product NDC
50242-132
11-digit product format
502420132
Labeler code
50242
Product ID
50242-132_5e75840c-4462-440a-9e17-caa80dd4127b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trastuzumab
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Genentech, Inc.
Application
BLA103792
Marketing category
BLA
Marketing start
2017-02-10
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

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

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1922509Internal RxNorm lookup
1922512Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
492dbdb2-077e-4064-bff3-372d6af0a7a2Available 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
50242-132-01Herceptin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,126
50242-132-01Herceptin15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1526
50242-132-10Herceptin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1026
50242-132-10Herceptin15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-132-01EA - Each50242-13257463a6f-9e34-44d8-8fc7-5785545ee60a12017-06-15
50242-132-10EA - Each50242-1327208e0ba-85f6-4923-91ba-0c850b30459912019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRASTUZUMABACTIVE INGREDIENTP188ANX8CKHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
TRASTUZUMABACTIVE MOIETYP188ANX8CKHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
HISTIDINEINACTIVE INGREDIENT4QD397987EHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
HISTIDINE MONOHYDROCHLORIDEINACTIVE INGREDIENT1D5Q932XM6HERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
TREHALOSE DIHYDRATEINACTIVE INGREDIENT7YIN7J07X4HERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-132HERCEPTIN (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]26Current NDC, Legacy NDC, 4 package rows20241121_492dbdb2-077e-4064-bff3-372d6af0a7a2.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
HerceptinTRASTUZUMABGenentech, Inc.492dbdb2-077e-4064-bff3-372d6af0a7a22026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103792
ndc (product): 50242-132

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103792Herceptintrastuzumab351(a)Disc*2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-132-01502420132011 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-01) / 15 mL in 1 VIAL, SINGLE-DOSE2017-02-100000-00-00NoNoCurrent
50242-132-105024201321010 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-10) > 15 mL in 1 VIAL, SINGLE-DOSE2019-06-030000-00-00NoNoCurrent