Home NDC 72893-002 Beleodaq
Product NDC 72893-002
11-digit product format 728930002
Labeler code 72893
Product ID 72893-002_0af69daf-c3eb-436a-b8d9-8ae89c5f0c85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Belinostat
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Acrotech Biopharma Inc
Application NDA206256
Marketing category NDA
Marketing start 2014-07-21
Substance BELINOSTAT
Active strength 500 mg/10mL
Pharmacologic classes Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA]
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 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# Additional Listing Data#
Finished product Yes
Brand name base Beleodaq
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BELINOSTAT 500 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F4H96P17NZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1543547 Internal RxNorm lookup 1543552 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 72893-002-01 Beleodaq 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 10 72893-002-01 Beleodaq 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72893-002 BELEODAQ (BELINOSTAT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACROTECH BIOPHARMA INC] 10 Current NDC, Legacy NDC, 2 package rows 20250409_2e8ef36b-71fa-4492-a16f-577d5f7d111d.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 72893-002-01 72893000201 1 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIAL 1 vial 2014-07-21 0000-00-00 No No Current