FDA.reportPublic FDA data

Herceptin Hylecta

Product NDC
50242-077
Requested package NDC
50242-077-01
11-digit product format
502420077
Labeler code
50242
Product ID
50242-077_6f91c20d-3654-4d9f-bfda-557364b1e7ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trastuzumab and hyaluronidase-oysk
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA761106
Marketing category
BLA
Marketing start
2019-02-28
Substance
HYALURONIDASE (HUMAN RECOMBINANT); TRASTUZUMAB
Active strength
10000; 600 U/5mL; mg/5mL
Pharmacologic classes
Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50242-07750242-077-01DDiscontinued by firm2026-09-14

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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRASTUZUMAB600 mg/5mL
HYALURONIDASE (HUMAN RECOMBINANT)10000 U/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P188ANX8CKInternal UNII lookup
743QUY4VD8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2119714Internal RxNorm lookup
2119719Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebf30894-41cf-480c-8bc3-56f592a13813Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fba5a780-b52d-4964-b662-1526b044aec4Product name120260127
64196b0b-840e-435b-8afa-0b0e9d9cea99Product name120251024
4b151d8d-9b47-43df-bccb-6abc1c4e7194Product name120250331
d745a796-f789-46a3-afa3-79dead22a863Product name120250331
00bb4496-246c-4f2c-910a-2b2783035958Product name120231025
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
6d78c268-2e9d-bd45-9f2d-965fd0e582caProduct name220200323
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
9397f6d4-17a1-42b4-beda-fa2c0ea40c8cProduct name120190610
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50242-077-012024-01-30C16284748780-11030e365-60a0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HERCEPTIN HYLECTA safely and effectively. See full prescribing information for HERCEPTIN HYLECTA. HERCEPTIN HYLECTA® (trastuzumab and hyaluronidase-oysk) injection, for subcutaneous use Initial U.S. Approval: 2019
50242-077-012024-01-30C16284748780-11030e365-60a0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HERCEPTIN HYLECTA safely and effectively. See full prescribing information for HERCEPTIN HYLECTA. HERCEPTIN HYLECTA® (trastuzumab and hyaluronidase-oysk) injection, for subcutaneous use Initial U.S. Approval: 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-077-01Herceptin Hylecta1 in 1 CARTONINJECTION, SOLUTION110
50242-077-01Herceptin Hylecta5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-077-01ML - Milliliter50242-077afbde225-7ac2-4673-bbcc-df03c283243d12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-077HERCEPTIN HYLECTA (TRASTUZUMAB AND HYALURONIDASE-OYSK) INJECTION, SOLUTION [GENENTECH, INC.]7Current NDC, Legacy NDC, 2 package rows20241127_ebf30894-41cf-480c-8bc3-56f592a13813.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
Herceptin HylectaTRASTUZUMAB AND HYALURONIDASE-OYSKGenentech, Inc.ebf30894-41cf-480c-8bc3-56f592a138132026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761106
ndc (package): 50242-077-01
ndc (product): 50242-077
ndc11 (package): 50242007701

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761106Herceptin Hylectatrastuzumab and hyaluronidase-oysk351(a)Rx2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-077-01502420077011 VIAL, SINGLE-DOSE in 1 CARTON (50242-077-01) / 5 mL in 1 VIAL, SINGLE-DOSE2019-02-280000-00-00NoNoCurrent