Home NDC 59572-984 ISTODAX
Product NDC 59572-984
11-digit product format 595720984
Labeler code 59572
Product ID 59572-984_08c46856-2700-4885-ba5d-dced9d8056e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name romidepsin
Dosage form KIT
Labeler Celgene Corporation
Application NDA022393
Marketing category NDA
Marketing start 2010-01-04
NDC exclude flag No
Listing certified through 2026-12-31
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 N022393-001 ISTODAX ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022393-001 AP
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 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-11-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022393-001 ISTODAX 10MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2009-11-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022393-001 7608280 2021-08-22 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022393-001 7611724 2021-08-22 Drug substance 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N022393-001 7608280 2021-08-22 Drug substance 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022393-001 7611724 2021-08-22 Drug substance 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022393-001 7608280 2021-08-22 Drug substance 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022393-001 7611724 2021-08-22 Drug substance 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022393-001 7608280 2021-08-22 Drug substance 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022393-001 7611724 2021-08-22 Drug substance 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022393-001 7608280 2021-08-22 Drug substance 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022393-001 7611724 2021-08-22 Drug substance 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022393-001 7608280 2021-08-22 Drug substance c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022393-001 7611724 2021-08-22 Drug substance c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022393-001 7608280 2021-08-22 Drug substance 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022393-001 7611724 2021-08-22 Drug substance 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022393-001 7608280 2021-08-22 Drug substance b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022393-001 7611724 2021-08-22 Drug substance b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022393-001 7608280 2021-08-22 Drug substance ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022393-001 7611724 2021-08-22 Drug substance ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base ISTODAX
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 877513 Internal RxNorm lookup 877516 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 59572-962-10 ISTODAX 2.2 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 2.2 mL 10 mg in 2mL 21 59572-984-01 ISTODAX 1 in 1 CARTON KIT 1 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59572-984 ISTODAX (ROMIDEPSIN) KIT [CELGENE CORPORATION] 21 Current NDC, Legacy NDC, 2 package rows 20230603_03b39d40-90fe-11df-9de6-0002a5d5c51b.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 59572-962-10 59572096210 2.2 mL in 1 VIAL, GLASS 2.2 ml Historical 59572-984-01 59572098401 1 KIT in 1 CARTON (59572-984-01) * 2.2 mL in 1 VIAL, GLASS (59572-962-10) * 2.4 mL in 1 VIAL, GLASS (59572-973-02) 1 kit 2010-01-04 0000-00-00 No No Current