YONDELIS
- Product NDC
- 59676-610
- 11-digit product format
- 596760610
- Labeler code
- 59676
- Product ID
- 59676-610_354fa826-08c3-4ce1-b1fb-16e63ad09253
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trabectedin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Janssen Products, LP
- Application
- NDA207953
- Marketing category
- NDA
- Marketing start
- 2015-10-23
- Substance
- TRABECTEDIN
- Active strength
- .05 mg/mL
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- YONDELIS
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRABECTEDIN | .05 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ID0YZQ2TCP |
| Rxcui | 1718589, 1718594 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59676-610-01 | YONDELIS | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Trabectedin | ACTIVE INGREDIENT | ID0YZQ2TCP | YONDELIS (TRABECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN PRODUCTS, LP] | 1 | |
| Trabectedin | ACTIVE MOIETY | ID0YZQ2TCP | YONDELIS (TRABECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN PRODUCTS, LP] | 1 | |
| Phosphoric Acid | INACTIVE INGREDIENT | E4GA8884NN | YONDELIS (TRABECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN PRODUCTS, LP] | 1 | |
| Potassium Hydroxide | INACTIVE INGREDIENT | WZH3C48M4T | YONDELIS (TRABECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN PRODUCTS, LP] | 1 | |
| Potassium Phosphate, Monobasic | INACTIVE INGREDIENT | 4J9FJ0HL51 | YONDELIS (TRABECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN PRODUCTS, LP] | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | YONDELIS (TRABECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN PRODUCTS, LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59676-610 | YONDELIS (TRABECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN PRODUCTS, LP] | 13 | Current NDC, Legacy NDC, 1 package rows | 20241220_472bd78e-be17-4b9d-90f4-9482c3aec9ff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59676-610-01 | 59676061001 | 20 mL in 1 VIAL, SINGLE-USE (59676-610-01) | 20 ml | 2015-10-23 | 0000-00-00 | No | No | Current |