Home NDC 73555-500-00 Revuforj
Product NDC 73555-500
Requested package NDC 73555-500-00
11-digit product format 735550500
Labeler code 73555
Product ID 73555-500_76183831-b710-4be2-a6a7-9349dd501830
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name revumenib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Syndax Pharmaceuticals, Inc.
Application NDA218944
Marketing category NDA
Marketing start 2024-11-15
Substance REVUMENIB CITRATE
Active strength 25 mg/1
Pharmacologic classes Menin Inhibitor [EPC], Menin Inhibitors [MoA]
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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218944-001 REVUFORJ REVUMENIB CITRATE EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 N218944-002 REVUFORJ REVUMENIB CITRATE EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 N218944-003 REVUFORJ REVUMENIB CITRATE EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218944-001 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 N218944-001 11479557 2037-06-08 U-4045 Drug product 2024-12-13 N218944-001 11479557 2037-06-08 U-4327 Drug product 2024-12-13 N218944-001 12564590 2042-12-18 U-4045 Drug product 2026-03-31 N218944-001 12564590 2042-12-18 U-4327 Drug product 2026-03-31 N218944-002 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 N218944-002 11479557 2037-06-08 U-4045 Drug product 2024-12-13 N218944-002 11479557 2037-06-08 U-4327 Drug product 2024-12-13 N218944-002 12564590 2042-12-18 U-4045 Drug product 2026-03-31 N218944-002 12564590 2042-12-18 U-4327 Drug product 2026-03-31 N218944-003 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 N218944-003 11479557 2037-06-08 U-4045 Drug product 2024-12-13 N218944-003 11479557 2037-06-08 U-4327 Drug product 2024-12-13 N218944-003 12564590 2042-12-18 U-4045 Drug product 2026-03-31 N218944-003 12564590 2042-12-18 U-4327 Drug product 2026-03-31
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 matching rows.
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 2026-10-15 13:18:30 2026-09 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218944-001 REVUFORJ EQ 25MG BASE TABLET / ORAL RLD 2024-11-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218944-002 REVUFORJ EQ 110MG BASE TABLET / ORAL RLD 2024-11-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218944-003 REVUFORJ EQ 160MG BASE TABLET / ORAL RLD, RS 2024-11-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 102 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N218944-001 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-001 11479557 2037-06-08 U-4327 Drug product 2024-12-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-001 11479557 2037-06-08 U-4045 Drug product 2024-12-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-001 12564590 2042-12-18 U-4045 Drug product 2026-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-001 12564590 2042-12-18 U-4327 Drug product 2026-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-002 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-002 11479557 2037-06-08 U-4327 Drug product 2024-12-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-002 11479557 2037-06-08 U-4045 Drug product 2024-12-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-002 12564590 2042-12-18 U-4327 Drug product 2026-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-002 12564590 2042-12-18 U-4045 Drug product 2026-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-003 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-003 11479557 2037-06-08 U-4327 Drug product 2024-12-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-003 11479557 2037-06-08 U-4045 Drug product 2024-12-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-003 12564590 2042-12-18 U-4327 Drug product 2026-03-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218944-003 12564590 2042-12-18 U-4045 Drug product 2026-03-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218944-001 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-001 11479557 2037-06-08 U-4327 Drug product 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-001 11479557 2037-06-08 U-4045 Drug product 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-001 12564590 2042-12-18 U-4045 Drug product 2026-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-001 12564590 2042-12-18 U-4327 Drug product 2026-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-002 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-002 11479557 2037-06-08 U-4327 Drug product 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-002 11479557 2037-06-08 U-4045 Drug product 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-002 12564590 2042-12-18 U-4327 Drug product 2026-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-002 12564590 2042-12-18 U-4045 Drug product 2026-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-003 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-003 11479557 2037-06-08 U-4327 Drug product 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-003 11479557 2037-06-08 U-4045 Drug product 2024-12-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-003 12564590 2042-12-18 U-4327 Drug product 2026-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218944-003 12564590 2042-12-18 U-4045 Drug product 2026-03-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218944-001 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-001 11479557 2037-06-08 U-4327 Drug product 2024-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-001 11479557 2037-06-08 U-4045 Drug product 2024-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-001 12564590 2042-12-18 U-4045 Drug product 2026-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-001 12564590 2042-12-18 U-4327 Drug product 2026-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-002 10683302 2037-06-08 Drug substance, Drug product 2024-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-002 11479557 2037-06-08 U-4327 Drug product 2024-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-002 11479557 2037-06-08 U-4045 Drug product 2024-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-002 12564590 2042-12-18 U-4327 Drug product 2026-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218944-002 12564590 2042-12-18 U-4045 Drug product 2026-03-31 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 117 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Revuforj
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REVUMENIB CITRATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YL4RYN734D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2698331 Internal RxNorm lookup 2698337 Internal RxNorm lookup 2698339 Internal RxNorm lookup 2698341 Internal RxNorm lookup 2698343 Internal RxNorm lookup 2698345 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 73555-500-00 Revuforj 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73555-500 REVUFORJ (REVUMENIB) TABLET, FILM COATED [SYNDAX PHARMACEUTICALS, INC.] 2 Current NDC, 1 package rows 20250426_6eb3cdbc-0e74-477d-82d6-3bb172d3f63f.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 Sample Exclude flag Status 73555-500-00 73555050000 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-500-00) 2024-11-15 No No Current