Home NDC 59572-710 Idhifa
Product NDC 59572-710
11-digit product format 595720710
Labeler code 59572
Product ID 59572-710_32634006-49db-4043-b84b-65f7f54b142d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name enasidenib mesylate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Celgene Corporation
Application NDA209606
Marketing category NDA
Marketing start 2017-08-01
Substance ENASIDENIB MESYLATE
Active strength 100 mg/1
Pharmacologic classes Isocitrate Dehydrogenase 2 Inhibitor [EPC], Isocitrate Dehydrogenase 2 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209606-001 IDHIFA ENASIDENIB MESYLATE EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 N209606-002 IDHIFA ENASIDENIB MESYLATE EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209606-001 10610125 2030-06-21 U-2087 2020-05-01 N209606-001 10294215 2033-01-07 U-2087 Drug product 2019-06-20 N209606-001 9512107 2033-01-07 U-2087 Drug substance, Drug product 2017-08-29 N209606-001 10093654 2034-08-01 U-2087 Drug substance, Drug product 2018-11-07 N209606-001 9738625 2034-08-01 Drug substance 2017-08-29 N209606-001 9732062 2034-09-16 Drug substance 2017-08-29 N209606-002 10610125 2030-06-21 U-2087 2020-05-01 N209606-002 10294215 2033-01-07 U-2087 Drug product 2019-06-20 N209606-002 9512107 2033-01-07 U-2087 Drug substance, Drug product 2017-08-29 N209606-002 10093654 2034-08-01 U-2087 Drug substance, Drug product 2018-11-07 N209606-002 9738625 2034-08-01 Drug substance 2017-08-29 N209606-002 9732062 2034-09-16 Drug substance 2017-08-29
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 3 · 82 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 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209606-001 IDHIFA EQ 50MG BASE TABLET / ORAL RLD 2017-08-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N209606-002 IDHIFA EQ 100MG BASE TABLET / ORAL RLD, RS 2017-08-01 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 13 · 484 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 N209606-001 10610125 2030-06-21 U-2087 2020-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-001 10294215 2033-01-07 U-2087 Drug product 2019-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-001 9512107 2033-01-07 U-2087 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-001 10093654 2034-08-01 U-2087 Drug substance, Drug product 2018-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-001 9738625 2034-08-01 Drug substance 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-001 9732062 2034-09-16 Drug substance 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-002 10610125 2030-06-21 U-2087 2020-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-002 10294215 2033-01-07 U-2087 Drug product 2019-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-002 9512107 2033-01-07 U-2087 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-002 10093654 2034-08-01 U-2087 Drug substance, Drug product 2018-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-002 9738625 2034-08-01 Drug substance 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209606-002 9732062 2034-09-16 Drug substance 2017-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-001 10610125 2030-06-21 U-2087 2020-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-001 10294215 2033-01-07 U-2087 Drug product 2019-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-001 9512107 2033-01-07 U-2087 Drug substance, Drug product 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-001 10093654 2034-08-01 U-2087 Drug substance, Drug product 2018-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-001 9738625 2034-08-01 Drug substance 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-001 9732062 2034-09-16 Drug substance 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-002 10610125 2030-06-21 U-2087 2020-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-002 10294215 2033-01-07 U-2087 Drug product 2019-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-002 9512107 2033-01-07 U-2087 Drug substance, Drug product 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-002 10093654 2034-08-01 U-2087 Drug substance, Drug product 2018-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-002 9738625 2034-08-01 Drug substance 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209606-002 9732062 2034-09-16 Drug substance 2017-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209606-001 10610125 2030-06-21 U-2087 2020-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-001 10294215 2033-01-07 U-2087 Drug product 2019-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-001 9512107 2033-01-07 U-2087 Drug substance, Drug product 2017-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-001 10093654 2034-08-01 U-2087 Drug substance, Drug product 2018-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-001 9738625 2034-08-01 Drug substance 2017-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-001 9732062 2034-09-16 Drug substance 2017-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-002 10610125 2030-06-21 U-2087 2020-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-002 10294215 2033-01-07 U-2087 Drug product 2019-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-002 9512107 2033-01-07 U-2087 Drug substance, Drug product 2017-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-002 10093654 2034-08-01 U-2087 Drug substance, Drug product 2018-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-002 9738625 2034-08-01 Drug substance 2017-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209606-002 9732062 2034-09-16 Drug substance 2017-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209606-001 10610125 2030-06-21 U-2087 2020-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209606-001 10294215 2033-01-07 U-2087 Drug product 2019-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209606-001 9512107 2033-01-07 U-2087 Drug substance, Drug product 2017-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209606-001 10093654 2034-08-01 U-2087 Drug substance, Drug product 2018-11-07 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 106 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Idhifa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENASIDENIB MESYLATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UF6PC17XAV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1940370 Internal RxNorm lookup 1940372 Internal RxNorm lookup 1940374 Internal RxNorm lookup 1940376 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 59572-710-30 Idhifa 30 in 1 BOTTLE TABLET, FILM COATED 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59572-710 IDHIFA (ENASIDENIB MESYLATE) TABLET, FILM COATED [CELGENE CORPORATION] 12 Current NDC, Legacy NDC, 1 package rows 20250130_a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Idhifa ENASIDENIB MESYLATE Celgene Corporation a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6 2025-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209606 application number: NDA209606 ndc (product): 59572-710
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 59572-710-30 59572071030 30 TABLET, FILM COATED in 1 BOTTLE (59572-710-30) 2017-08-01 0000-00-00 No No Current