Home NDC 63323-926 Romidepsin
Product NDC 63323-926
11-digit product format 633230926
Labeler code 63323
Product ID 63323-926_44fb8ff4-ec3d-4dcf-8e8c-207545d938a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Romidepsin
Dosage form KIT
Labeler Fresenius Kabi USA, LLC
Application ANDA206254
Marketing category ANDA
Marketing start 2021-10-12
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 A206254-001 ROMIDEPSIN ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206254-001 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.
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 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206254-001 ROMIDEPSIN 10MG/VIAL POWDER / INTRAVENOUS AP 2021-10-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Romidepsin
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 877513 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 63323-925-17 Romidepsin 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 2 mL 10 mg in 2mL 9 63323-926-88 Romidepsin 1 in 1 CARTON KIT 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-926 ROMIDEPSIN KIT [FRESENIUS KABI USA, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20211124_73a2028d-6735-4cd4-b63d-d072df9927a1.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 63323-925-17 63323092517 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 63323-926-88 63323092688 1 KIT in 1 CARTON (63323-926-88) * 2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17) * 2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03) 1 kit 2021-10-12 0000-00-00 No No Current