herceptin hylecta

Generic: trastuzumab and hyaluronidase-oysk

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name herceptin hylecta
Generic Name trastuzumab and hyaluronidase-oysk
Labeler genentech, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

hyaluronidase (human recombinant) 10000 U/5mL, trastuzumab 600 mg/5mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-077
Product ID 50242-077_6f91c20d-3654-4d9f-bfda-557364b1e7ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761106
Listing Expiration 2026-12-31
Marketing Start 2019-02-28

Pharmacologic Class

Established (EPC)
endoglycosidase [epc] her2/neu receptor antagonist [epc]
Mechanism of Action
her2/neu/cerbb2 antagonists [moa]
Chemical Structure
glycoside hydrolases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242077
Hyphenated Format 50242-077

Supplemental Identifiers

RxCUI
2119714 2119719
UNII
743QUY4VD8 P188ANX8CK
NUI
N0000175531 M0009499 N0000175661 N0000020008

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name herceptin hylecta (source: ndc)
Generic Name trastuzumab and hyaluronidase-oysk (source: ndc)
Application Number BLA761106 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10000 U/5mL
  • 600 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-077-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

50242-077-01 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-077-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

hyaluronidase (human recombinant) (10000 U/5mL) trastuzumab (600 mg/5mL)

Linked Drug Pages (1)

Herceptin Hylecta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "6f91c20d-3654-4d9f-bfda-557364b1e7ea", "openfda": {"nui": ["N0000175531", "M0009499", "N0000175661", "N0000020008"], "unii": ["743QUY4VD8", "P188ANX8CK"], "rxcui": ["2119714", "2119719"], "spl_set_id": ["ebf30894-41cf-480c-8bc3-56f592a13813"], "pharm_class_cs": ["Glycoside Hydrolases [CS]"], "pharm_class_epc": ["Endoglycosidase [EPC]", "HER2/neu Receptor Antagonist [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (50242-077-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50242-077-01", "marketing_start_date": "20190228"}], "brand_name": "Herceptin Hylecta", "product_id": "50242-077_6f91c20d-3654-4d9f-bfda-557364b1e7ea", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]", "HER2/Neu/cerbB2 Antagonists [MoA]", "HER2/neu Receptor Antagonist [EPC]"], "product_ndc": "50242-077", "generic_name": "Trastuzumab and hyaluronidase-oysk", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Herceptin Hylecta", "active_ingredients": [{"name": "HYALURONIDASE (HUMAN RECOMBINANT)", "strength": "10000 U/5mL"}, {"name": "TRASTUZUMAB", "strength": "600 mg/5mL"}], "application_number": "BLA761106", "marketing_category": "BLA", "marketing_start_date": "20190228", "listing_expiration_date": "20261231"}