FDA.reportPublic FDA data

Herceptin Hylecta

Product NDC
50242-077
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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii743QUY4VD8, P188ANX8CK

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

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