Home NDC 59676-610 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207953-001 YONDELIS TRABECTEDIN 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207953-001 8895557 2028-01-07 Drug product 2015-11-20 N207953-001 8895557*PED 2028-07-07 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207953-001 YONDELIS 1MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-10-23 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207953-001 8895557*PED 2028-07-07 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207953-001 8895557*PED 2028-07-07 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207953-001 8895557*PED 2028-07-07 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207953-001 8895557*PED 2028-07-07 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207953-001 8895557*PED 2028-07-07 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207953-001 8895557*PED 2028-07-07 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207953-001 8895557*PED 2028-07-07 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207953-001 8895557*PED 2028-07-07 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207953-001 8895557*PED 2028-07-07 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207953-001 8895557*PED 2028-07-07 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207953-001 8895557*PED 2028-07-07 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207953-001 8895557*PED 2028-07-07 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207953-001 8895557*PED 2028-07-07 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207953-001 8895557*PED 2028-07-07 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207953-001 8895557*PED 2028-07-07 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207953-001 8895557*PED 2028-07-07 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207953-001 8895557*PED 2028-07-07 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207953-001 8895557*PED 2028-07-07 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207953-001 8895557*PED 2028-07-07 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207953-001 8895557 2028-01-07 Drug product 2015-11-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N207953-001 8895557*PED 2028-07-07 Pediatric extension 782e0a99824c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 75 observed states.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ID0YZQ2TCP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1718589 Internal RxNorm lookup 1718594 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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