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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75788-115DDiscontinued by firm2026-09-14
excluded packagepackage75788-11575788-115-04DDiscontinued by firm2026-09-14

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct75788-115DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage75788-11575788-115-04DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214900-001BREXAFEMMEIBREXAFUNGERP CITRATEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214900-00181880852030-08-28U-3159Drug substance, Drug product2021-06-30
N214900-001101740742035-01-19Drug substance, Drug product2021-06-30
N214900-001103704062035-01-19U-31592021-06-30
N214900-001109271422035-01-19Drug substance2021-06-30
N214900-001115344332039-06-10U-31592023-01-24
N214900-001115344332039-06-10U-35082023-01-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214900-001NCE2026-06-01
N214900-001GAIN2031-06-01

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-0184e616aacf4f…
2026-08-18 06:07:402026-07N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-013f0d92c62455…
2023-05-13 08:27 UTC2023-05N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01053a50430f4f…
2023-01-26 05:58 UTC2023-01N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214900-001BREXAFEMMEEQ 150MG BASETABLET / ORALRLD, RS2021-06-01a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 190 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N214900-00181880852030-08-28U-3159Drug substance, Drug product2021-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N214900-001101740742035-01-19Drug substance, Drug product2021-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N214900-001103704062035-01-19U-31592021-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N214900-001109271422035-01-19Drug substance2021-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N214900-001115344332039-06-10U-31592023-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N214900-001115344332039-06-10U-35082023-01-2484e616aacf4f…
2026-08-18 06:07:402026-07N214900-00181880852030-08-28U-3159Drug substance, Drug product2021-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07N214900-001101740742035-01-19Drug substance, Drug product2021-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07N214900-001103704062035-01-19U-31592021-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07N214900-001109271422035-01-19Drug substance2021-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07N214900-001115344332039-06-10U-31592023-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N214900-001115344332039-06-10U-35082023-01-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214900-00181880852030-08-28U-3159Drug substance, Drug product2021-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214900-001101740742035-01-19Drug substance, Drug product2021-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214900-001103704062035-01-19U-31592021-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214900-001109271422035-01-19Drug substance2021-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214900-001115344332039-06-10U-31592023-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214900-001115344332039-06-10U-35082023-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-00181880852030-08-28U-3159Drug substance, Drug product2021-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-001101740742035-01-19Drug substance, Drug product2021-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-001103704062035-01-19U-31592021-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-001109271422035-01-19Drug substance2021-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-001115344332039-06-10U-31592023-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-001115344332039-06-10U-35082023-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N214900-00181880852030-08-28U-3159Drug substance, Drug product2021-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214900-001101740742035-01-19Drug substance, Drug product2021-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214900-001103704062035-01-19U-31592021-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214900-001109271422035-01-19Drug substance2021-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214900-001115344332039-06-10U-31592023-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214900-001115344332039-06-10U-35082023-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-00181880852030-08-28U-3159Drug substance, Drug product2021-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-001101740742035-01-19Drug substance, Drug product2021-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-001103704062035-01-19U-31592021-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-001109271422035-01-19Drug substance2021-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-001115344332039-06-10U-31592023-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-001115344332039-06-10U-35082023-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214900-00181880852030-08-28U-3159Drug substance, Drug product2021-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214900-001101740742035-01-19Drug substance, Drug product2021-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214900-001103704062035-01-19U-31592021-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214900-001109271422035-01-19Drug substance2021-06-30b8a1b40f171c…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 91 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N214900-001NCE2026-06-0184e616aacf4f…
2026-09-14 22:38:342026-08N214900-001GAIN2031-06-0184e616aacf4f…
2026-08-18 06:07:402026-07N214900-001NCE2026-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07N214900-001GAIN2031-06-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214900-001NCE2026-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214900-001GAIN2031-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-001I-9032025-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-001NCE2026-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214900-001GAIN2031-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214900-001I-9032025-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214900-001NCE2026-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214900-001GAIN2031-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-001I-9032025-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-001NCE2026-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214900-001GAIN2031-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214900-001I-9032025-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214900-001NCE2026-06-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214900-001GAIN2031-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214900-001I-9032025-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214900-001NCE2026-06-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214900-001GAIN2031-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214900-001I-9032025-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214900-001NCE2026-06-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214900-001GAIN2031-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214900-001I-9032025-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214900-001NCE2026-06-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214900-001GAIN2031-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214900-001I-9032025-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214900-001NCE2026-06-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214900-001GAIN2031-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214900-001I-9032025-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N214900-001NCE2026-06-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N214900-001GAIN2031-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214900-001I-9032025-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214900-001NCE2026-06-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214900-001GAIN2031-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214900-001I-9032025-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214900-001NCE2026-06-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214900-001GAIN2031-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214900-001I-9032025-11-301e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c35b142d-fa78-42b6-96f7-3c2a966a1bd4Product name120210903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75788-115-04EA - Each75788-1156d1ca89c-22f6-4571-9b3d-f73d1c0ca80012021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75788-115BREXAFEMME (IBREXAFUNGERP) TABLET, FILM COATED [SCYNEXIS, INC.]10Legacy NDC20241105_c33be3a1-c4fd-512c-e053-2995a90a63eb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75788-115-04757880115041 BLISTER PACK in 1 CARTON (75788-115-04) > 4 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-07-010000-00-00NoNoCurrent