NDC 59676-610

YONDELIS

Trabectedin

YONDELIS is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Products, Lp. The primary component is Trabectedin.

• Product ID: 59676-610_8218989c-639a-11ea-bb8e-0434fc2ca371
• NDC: 59676-610
• Product Type: Human Prescription Drug
• Proprietary Name: YONDELIS
• Generic Name: Trabectedin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-10-23
• Marketing Category: NDA / NDA
• Application Number: NDA207953
• Labeler Name: Janssen Products, LP
• Substance Name: TRABECTEDIN
• Active Ingredient Strength: 0 mg/mL
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 59676-610-01

20 mL in 1 VIAL, SINGLE-USE (59676-610-01)

• Marketing Start Date: 2015-10-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59676-610-01 [59676061001]

YONDELIS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA207953
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-23

Drug Details

Active Ingredients

Ingredient	Strength
TRABECTEDIN	.05 mg/mL

OpenFDA Data

• SPL SET ID: 472bd78e-be17-4b9d-90f4-9482c3aec9ff
• Manufacturer:
  • Janssen Products, LP
• UNII:
  • ID0YZQ2TCP
• RxNorm Concept Unique ID - RxCUI:
  • 1718594
  • 1718589

Pharmacological Class

• Alkylating Activity [MoA]
• Alkylating Drug [EPC]
• Alkylating Activity [MoA]
• Alkylating Drug [EPC]