NDC 65597-406

Enhertu

Fam-trastuzumab Deruxtecan-nxki

Enhertu is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Daiichi Sankyo, Inc.. The primary component is Trastuzumab Deruxtecan.

• Product ID: 65597-406_2941ff87-6750-4d3f-b2d5-431dc740ebb9
• NDC: 65597-406
• Product Type: Human Prescription Drug
• Proprietary Name: Enhertu
• Generic Name: Fam-trastuzumab Deruxtecan-nxki
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-12-20
• Marketing Category: BLA / BLA
• Application Number: BLA761139
• Labeler Name: Daiichi Sankyo, Inc.
• Substance Name: TRASTUZUMAB DERUXTECAN
• Active Ingredient Strength: 100 mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 65597-406-01

1 VIAL, SINGLE-DOSE in 1 CARTON (65597-406-01) > 5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-12-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65597-406-01 [65597040601]

Enhertu INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761139
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-12-20

Drug Details

Active Ingredients

Ingredient	Strength
TRASTUZUMAB DERUXTECAN	100 mg/5mL