yondelis

Generic: trabectedin

Labeler: janssen products, lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name yondelis
Generic Name trabectedin
Labeler janssen products, lp
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

trabectedin .05 mg/mL

Manufacturer
Janssen Products, LP

Identifiers & Regulatory

Product NDC 59676-610
Product ID 59676-610_354fa826-08c3-4ce1-b1fb-16e63ad09253
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207953
Listing Expiration 2027-12-31
Marketing Start 2015-10-23

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59676610
Hyphenated Format 59676-610

Supplemental Identifiers

RxCUI
1718589 1718594
UNII
ID0YZQ2TCP
NUI
N0000000236 N0000175558

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 yondelis (source: ndc)
Generic Name trabectedin (source: ndc)
Application Number NDA207953 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 20 mL in 1 VIAL, SINGLE-USE (59676-610-01)
source: ndc

Packages (1)

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

Ingredients (1)

trabectedin (.05 mg/mL)

Linked Drug Pages (1)

YONDELIS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "354fa826-08c3-4ce1-b1fb-16e63ad09253", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["ID0YZQ2TCP"], "rxcui": ["1718589", "1718594"], "spl_set_id": ["472bd78e-be17-4b9d-90f4-9482c3aec9ff"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Janssen Products, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL, SINGLE-USE (59676-610-01)", "package_ndc": "59676-610-01", "marketing_start_date": "20151023"}], "brand_name": "YONDELIS", "product_id": "59676-610_354fa826-08c3-4ce1-b1fb-16e63ad09253", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "59676-610", "generic_name": "Trabectedin", "labeler_name": "Janssen Products, LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "YONDELIS", "active_ingredients": [{"name": "TRABECTEDIN", "strength": ".05 mg/mL"}], "application_number": "NDA207953", "marketing_category": "NDA", "marketing_start_date": "20151023", "listing_expiration_date": "20271231"}