Home NDC 75788-115 BREXAFEMME
Product NDC 75788-115
11-digit product format 757880115
Labeler code 75788
Product ID 75788-115_efcbb80d-f475-c173-e053-2995a90a1e81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ibrexafungerp
Dosage form TABLET, FILM COATED
Route ORAL
Labeler SCYNEXIS, INC.
Application NDA214900
Marketing category NDA
Marketing start 2021-07-01
Marketing end 0000-00-00
Substance IBREXAFUNGERP CITRATE
Active strength 150 mg/1
Pharmacologic classes Glucan Synthase Inhibitors [MoA], Triterpenes [CS], Triterpenoid Antifungal [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 75788-115 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 75788-115 75788-115-04 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N214900-001 BREXAFEMME IBREXAFUNGERP CITRATE EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214900-001 8188085 2030-08-28 U-3159 Drug substance, Drug product 2021-06-30 N214900-001 10174074 2035-01-19 Drug substance, Drug product 2021-06-30 N214900-001 10370406 2035-01-19 U-3159 2021-06-30 N214900-001 10927142 2035-01-19 Drug substance 2021-06-30 N214900-001 11534433 2039-06-10 U-3159 2023-01-24 N214900-001 11534433 2039-06-10 U-3508 2023-01-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214900-001 NCE 2026-06-01 N214900-001 GAIN 2031-06-01
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 2026-09-14 22:38:34 2026-08 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214900-001 BREXAFEMME EQ 150MG BASE TABLET / ORAL RLD, RS 2021-06-01 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 190 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N214900-001 8188085 2030-08-28 U-3159 Drug substance, Drug product 2021-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214900-001 10174074 2035-01-19 Drug substance, Drug product 2021-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214900-001 10370406 2035-01-19 U-3159 2021-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214900-001 10927142 2035-01-19 Drug substance 2021-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214900-001 11534433 2039-06-10 U-3159 2023-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214900-001 11534433 2039-06-10 U-3508 2023-01-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214900-001 8188085 2030-08-28 U-3159 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214900-001 10174074 2035-01-19 Drug substance, Drug product 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214900-001 10370406 2035-01-19 U-3159 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214900-001 10927142 2035-01-19 Drug substance 2021-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214900-001 11534433 2039-06-10 U-3159 2023-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214900-001 11534433 2039-06-10 U-3508 2023-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214900-001 8188085 2030-08-28 U-3159 Drug substance, Drug product 2021-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214900-001 10174074 2035-01-19 Drug substance, Drug product 2021-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214900-001 10370406 2035-01-19 U-3159 2021-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214900-001 10927142 2035-01-19 Drug substance 2021-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214900-001 11534433 2039-06-10 U-3159 2023-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214900-001 11534433 2039-06-10 U-3508 2023-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214900-001 8188085 2030-08-28 U-3159 Drug substance, Drug product 2021-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214900-001 10174074 2035-01-19 Drug substance, Drug product 2021-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214900-001 10370406 2035-01-19 U-3159 2021-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214900-001 10927142 2035-01-19 Drug substance 2021-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214900-001 11534433 2039-06-10 U-3159 2023-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214900-001 11534433 2039-06-10 U-3508 2023-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214900-001 8188085 2030-08-28 U-3159 Drug substance, Drug product 2021-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214900-001 10174074 2035-01-19 Drug substance, Drug product 2021-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214900-001 10370406 2035-01-19 U-3159 2021-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214900-001 10927142 2035-01-19 Drug substance 2021-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214900-001 11534433 2039-06-10 U-3159 2023-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214900-001 11534433 2039-06-10 U-3508 2023-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214900-001 8188085 2030-08-28 U-3159 Drug substance, Drug product 2021-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214900-001 10174074 2035-01-19 Drug substance, Drug product 2021-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214900-001 10370406 2035-01-19 U-3159 2021-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214900-001 10927142 2035-01-19 Drug substance 2021-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214900-001 11534433 2039-06-10 U-3159 2023-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214900-001 11534433 2039-06-10 U-3508 2023-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214900-001 8188085 2030-08-28 U-3159 Drug substance, Drug product 2021-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214900-001 10174074 2035-01-19 Drug substance, Drug product 2021-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214900-001 10370406 2035-01-19 U-3159 2021-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214900-001 10927142 2035-01-19 Drug substance 2021-06-30 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 91 observed states.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75788-115 BREXAFEMME (IBREXAFUNGERP) TABLET, FILM COATED [SCYNEXIS, INC.] 10 Legacy NDC 20241105_c33be3a1-c4fd-512c-e053-2995a90a63eb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75788-115-04 75788011504 1 BLISTER PACK in 1 CARTON (75788-115-04) > 4 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2021-07-01 0000-00-00 No No Current