Home NDC 68727-712 ZEPZELCA
Product NDC 68727-712
11-digit product format 687270712
Labeler code 68727
Product ID 68727-712_846f5d71-faab-42a5-85d6-d83626b7bf3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lurbinectedin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Jazz Pharmaceuticals, Inc.
Application NDA213702
Marketing category NDA
Marketing start 2020-06-15
Substance LURBINECTEDIN
Active strength .5 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 42 .
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 N213702-001 ZEPZELCA LURBINECTEDIN 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 N213702-001 7763615 2029-12-13 U-4299 Drug substance, Drug product 2020-06-23 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 N213702-001 12433890 2040-05-29 U-4305 2025-11-06 N213702-001 12440490 2040-05-29 U-4252 2025-11-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213702-001 ODE-304 2027-06-15 N213702-001 I-977 2028-10-02
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.
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 2026-08-18 06:07:40 2026-07 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213702-001 ZEPZELCA 4MG/VIAL POWDER / INTRAVENOUS RLD, RS 2020-06-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 55 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N213702-001 7763615 2029-12-13 U-4299 Drug substance, Drug product 2020-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213702-001 12433890 2040-05-29 U-4305 2025-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213702-001 12440490 2040-05-29 U-4252 2025-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213702-001 7763615 2029-12-13 U-4299 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213702-001 12433890 2040-05-29 U-4305 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213702-001 12440490 2040-05-29 U-4252 2025-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 7763615 2029-12-13 U-4299 Drug substance, Drug product 2020-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 12433890 2040-05-29 U-4305 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213702-001 12440490 2040-05-29 U-4252 2025-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213702-001 12324806 2040-05-29 U-4212 2025-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213702-001 7763615 2024-12-13 U-2836 Drug substance, Drug product 2020-06-23 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213702-001 7763615 2029-12-13 U-2836 Drug substance, Drug product 2020-06-23 ea1830bbd6c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ZEPZELCA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LURBINECTEDIN .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2CN60TN6ZS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2374733 Internal RxNorm lookup 2374738 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 68727-712-01 ZEPZELCA 8 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 8 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68727-712 ZEPZELCA (LURBINECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250515_632bb50c-3bcb-4c85-9056-fc33410550ae.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 68727-712-01 68727071201 8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01) 8 ml 2020-06-15 0000-00-00 No No Current