Home NDC 0703-4004 Romidepsin
Product NDC 0703-4004
11-digit product format 007034004
Labeler code 0703
Product ID 0703-4004_125b3dd3-f589-45b0-8737-c88b1be4082c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Romidepsin
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application NDA208574
Marketing category NDA
Marketing start 2020-04-14
Marketing end 0000-00-00
Substance ROMIDEPSIN
Active strength 5 mg/mL
Pharmacologic classes Bile Salt Export Pump Inhibitors [MoA], Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 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 0703-4004-01 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 0703-4004-01 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208574-001 ROMIDEPSIN ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 N208574-002 ROMIDEPSIN ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13
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 · 74 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 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS RLD 2020-03-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2020-03-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-03-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2020-03-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-03-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2020-03-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-03-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2020-03-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-03-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2020-03-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-03-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208574-001 ROMIDEPSIN 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2020-03-13 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208574-002 ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-03-13 87673890dc5c…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0703-4004-01 00703400401 1 VIAL in 1 CARTON (0703-4004-01) > 5.5 mL in 1 VIAL 1 vial 2020-04-14 0000-00-00 No No Current