Home NDC 72607-100 TAZVERIK
Product NDC 72607-100
11-digit product format 726070100
Labeler code 72607
Product ID 72607-100_c4bd8d8a-22c1-4911-a9b4-7368582d8e5d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tazemetostat
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Epizyme, Inc.
Application NDA211723
Marketing category NDA
Marketing start 2020-01-23
Marketing end 2029-04-30
Substance TAZEMETOSTAT HYDROBROMIDE
Active strength 200 mg/1
Pharmacologic classes Methyltransferase Inhibitor [EPC], Methyltransferase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N211723-001 TAZVERIK TAZEMETOSTAT HYDROBROMIDE EQ 200MG BASE TABLET / ORAL RLD 2020-01-23
Orange Book patents# Current patent rows page 1 of 1 · 46 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211723-001 10155002 2031-09-12 U-2736 2020-02-19 N211723-001 10420775 2031-09-12 U-2736 2020-02-19 N211723-001 10420775 2031-09-12 U-2852 2020-02-19 N211723-001 10420775 2031-09-12 U-2853 2020-02-19 N211723-001 11052093 2031-09-12 U-2736 Drug substance, Drug product 2021-08-03 N211723-001 11052093 2031-09-12 U-2852 Drug substance, Drug product 2021-08-03 N211723-001 11052093 2031-09-12 U-2853 Drug substance, Drug product 2021-08-03 N211723-001 12161645 2031-09-12 U-2853 2025-01-10 N211723-001 12168015 2031-09-12 Drug substance, Drug product 2025-01-10 N211723-001 12168016 2031-09-12 U-2736 2025-01-10 N211723-001 12168016 2031-09-12 U-2853 2025-01-10 N211723-001 8691507 2031-09-12 U-2852 2020-07-16 N211723-001 8765732 2031-09-12 U-2852 2020-07-16 N211723-001 8765732 2031-09-12 U-2853 2020-07-16 N211723-001 8895245 2031-09-12 U-2852 2020-07-16 N211723-001 9090562 2031-09-12 Drug substance, Drug product 2020-02-19 N211723-001 9175331 2031-09-12 U-2852 2020-07-16 N211723-001 9333217 2031-09-12 U-2852 2020-07-16 N211723-001 9334527 2031-09-12 U-2852 2020-07-16 N211723-001 9549931 2031-09-12 U-2736 2020-02-19 N211723-001 9549931 2031-09-12 U-2852 2020-02-19 N211723-001 9549931 2031-09-12 U-2853 2020-02-19 N211723-001 9855275 2031-09-12 U-2736 2020-02-19 N211723-001 9949999 2031-09-12 U-2851 2020-07-16 N211723-001 10245269 2033-04-11 U-2737 2020-02-19 N211723-001 10245269 2033-04-11 U-2851 2020-02-19 N211723-001 10245269 2033-04-11 U-2854 2020-02-19 N211723-001 10821113 2033-04-11 Drug substance, Drug product 2020-11-24 N211723-001 11491163 2033-04-11 U-2736 2022-12-08 N211723-001 11491163 2033-04-11 U-2852 2022-12-08 N211723-001 11491163 2033-04-11 U-2853 2022-12-08 N211723-001 9394283 2033-04-11 U-2852 Drug substance, Drug product 2020-02-19 N211723-001 9394283 2033-04-11 U-2853 Drug substance, Drug product 2020-02-19 N211723-001 8410088 2034-01-23 Drug substance, Drug product 2020-02-19 N211723-001 12162865 2034-06-12 U-2736 2025-01-10 N211723-001 9688665 2034-08-22 U-2736 2020-02-19 N211723-001 10369155 2035-10-16 U-2736 2020-02-19 N211723-001 10369155 2035-10-16 U-2852 2020-02-19 N211723-001 10369155 2035-10-16 U-2853 2020-02-19 N211723-001 9889138 2035-10-16 U-2736 2020-02-19 N211723-001 9889138 2035-10-16 U-2852 2020-02-19 N211723-001 9889138 2035-10-16 U-2853 2020-02-19 N211723-001 10786511 2035-12-19 Drug product 2020-10-26 N211723-001 12168014 2038-05-03 U-2736 2025-01-16 N211723-001 12168014 2038-05-03 U-2852 2025-01-16 N211723-001 12168014 2038-05-03 U-2853 2025-01-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211723-001 ODE-299 2027-01-23 N211723-001 ODE-314 2027-06-18
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 2026-08-18 06:07:40 2026-07 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD 2020-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD, RS 2020-01-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211723-001 TAZVERIK EQ 200MG BASE TABLET / ORAL RLD 2020-01-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 37 · 1,465 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N211723-001 10155002 2031-09-12 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10420775 2031-09-12 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10420775 2031-09-12 U-2852 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10420775 2031-09-12 U-2853 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11052093 2031-09-12 U-2736 Drug substance, Drug product 2021-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11052093 2031-09-12 U-2852 Drug substance, Drug product 2021-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11052093 2031-09-12 U-2853 Drug substance, Drug product 2021-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12161645 2031-09-12 U-2853 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12168015 2031-09-12 Drug substance, Drug product 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12168016 2031-09-12 U-2736 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12168016 2031-09-12 U-2853 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8691507 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8765732 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8765732 2031-09-12 U-2853 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8895245 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9090562 2031-09-12 Drug substance, Drug product 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9175331 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9333217 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9334527 2031-09-12 U-2852 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9549931 2031-09-12 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9549931 2031-09-12 U-2853 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9549931 2031-09-12 U-2852 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9855275 2031-09-12 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9949999 2031-09-12 U-2851 2020-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10245269 2033-04-11 U-2737 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10245269 2033-04-11 U-2851 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10245269 2033-04-11 U-2854 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10821113 2033-04-11 Drug substance, Drug product 2020-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11491163 2033-04-11 U-2852 2022-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11491163 2033-04-11 U-2853 2022-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 11491163 2033-04-11 U-2736 2022-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9394283 2033-04-11 U-2852 Drug substance, Drug product 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9394283 2033-04-11 U-2853 Drug substance, Drug product 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 8410088 2034-01-23 Drug substance, Drug product 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 12162865 2034-06-12 U-2736 2025-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9688665 2034-08-22 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10369155 2035-10-16 U-2736 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10369155 2035-10-16 U-2853 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 10369155 2035-10-16 U-2852 2020-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211723-001 9889138 2035-10-16 U-2736 2020-02-19 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 151 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TAZVERIK Active Ingredients# Ingredient, Strength table Ingredient Strength TAZEMETOSTAT HYDROBROMIDE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6P89T5M073 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2274384 Internal RxNorm lookup 2274390 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 72607-100-00 TAZVERIK 240 in 1 BOTTLE TABLET, FILM COATED 240 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72607-100 TAZVERIK (TAZEMETOSTAT) TABLET, FILM COATED [EPIZYME, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20240820_7db07b5f-4e22-467c-9c0a-f830b08dbb1d.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 Marketing start Marketing end Sample Exclude flag Status 72607-100-00 72607010000 240 TABLET, FILM COATED in 1 BOTTLE (72607-100-00) 2020-01-23 2029-04-30 No No Current