NDC 50242-077

Herceptin Hylecta

Trastuzumab And Hyaluronidase-oysk

Herceptin Hylecta is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Trastuzumab; Hyaluronidase (human Recombinant).

• Product ID: 50242-077_73c7a56d-b4eb-47d6-ae89-4985da5b144c
• NDC: 50242-077
• Product Type: Human Prescription Drug
• Proprietary Name: Herceptin Hylecta
• Generic Name: Trastuzumab And Hyaluronidase-oysk
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-02-28
• Marketing Category: BLA / BLA
• Application Number: BLA761106
• Labeler Name: Genentech, Inc.
• Substance Name: TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)
• Active Ingredient Strength: 600 mg/5mL; U/5mL
• Pharm Classes: HER2/neu Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA],Endoglycosidase [EPC],Glycoside Hydrolases [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50242-077-01

1 VIAL, SINGLE-DOSE in 1 CARTON (50242-077-01) > 6 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-077-01 [50242007701]

Herceptin Hylecta INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761106
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-02-28

Drug Details

Active Ingredients

Ingredient	Strength
TRASTUZUMAB	600 mg/5mL

OpenFDA Data

• SPL SET ID: ebf30894-41cf-480c-8bc3-56f592a13813
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • P188ANX8CK
  • 8KOG53Z5EM
• RxNorm Concept Unique ID - RxCUI:
  • 2122495
  • 2122497

Pharmacological Class

• HER2/neu Receptor Antagonist [EPC]
• HER2/Neu/cerbB2 Antagonists [MoA]
• Endoglycosidase [EPC]
• Glycoside Hydrolases [CS]