Home NDC 69605-002 Beleodaq
Product NDC 69605-002
11-digit product format 696050002
Labeler code 69605
Product ID 69605-002_d44fda43-af8e-4cd6-e053-2a95a90ace50
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Belinostat
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler CENEXI - BLA
Application NDA206256
Marketing category NDA
Marketing start 2014-07-21
Marketing end 0000-00-00
Substance BELINOSTAT
Active strength 500 mg/10mL
Pharmacologic classes Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 N206256-001 BELEODAQ BELINOSTAT 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 N206256-001 8835501 2027-10-27 Drug product 2014-10-09
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 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206256-001 BELEODAQ 500MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-07-03 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206256-001 6888027 2021-09-27 U-1544 Drug substance, Drug product 2014-08-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206256-001 6888027 2026-08-10 U-1544 Drug substance, Drug product 2014-08-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N206256-001 8835501 2027-10-27 Drug product 2014-10-09 782e0a99824c…
Observed Orange Book exclusivity history# 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 Beleodaq BELINOSTAT Acrotech Biopharma Inc 2e8ef36b-71fa-4492-a16f-577d5f7d111d 2025-04-07 Warnings, Adverse reactions Exact identifier application applno (NDA): 206256 application number: NDA206256
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69605-002-01 69605000201 1 VIAL in 1 CARTON (69605-002-01) > 10 mL in 1 VIAL 1 vial 2014-07-21 0000-00-00 No No Current