Romidepsin

Product NDC: 0703-3125
11-digit product format: 007033125
Labeler code: 0703
Product ID: 0703-3125_c233310e-8e09-4a9a-a6fa-67fbb1c63d0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: romidepsin
Dosage form: KIT
Labeler: Teva Parenteral Medicines, Inc.
Application: NDA022393
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-07-31
Marketing end: 2021-10-31
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0703-3125		D	Discontinued by firm		2026-08-10
excluded package	package	0703-3125	0703-3125-08	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0703-3125-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0703-3125-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0703-3125-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0703-3125-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0703-3125-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0703-3125-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0703-3125-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0703-3125-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0703-3125-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0703-3125-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0703-3125-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0703-3125-08	`557ba5c1ecfa…`	`9c80585c8c6e…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022393-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022393-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022393-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022393-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022393-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022393-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022393-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022393-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022393-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022393-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022393-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022393-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022393-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022393-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022393-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022393-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022393-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022393-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022393-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022393-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022393-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022393-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022393-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022393-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022393-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022393-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022393-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022393-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022393-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022393-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022393-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022393-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022393-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0703-3125-08	EA - Each	0703-3125	4e3cae61-8565-44c5-9d3e-9867d4642ca2	1	2018-09-05

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISTODAX	ROMIDEPSIN	Celgene Corporation	03b39d40-90fe-11df-9de6-0002a5d5c51b	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022393 application number: NDA022393

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CX3T89XQBK	ROMIDEPSIN	128517-07-7	romidepsin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0703-3125-08	00703312508	1 KIT in 1 CARTON (0703-3125-08) * 2 mL in 1 VIAL, GLASS * 2 mL in 1 VIAL, GLASS	1 kit	2018-08-01	2021-10-31	No	No	Current