FDA.reportPublic FDA data

OGSIVEO

Product NDC
82448-100
11-digit product format
824480100
Labeler code
82448
Product ID
82448-100_39192daa-3e54-4741-adad-7d3742860396
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nirogacestat
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SpringWorks Therapeutics, Inc.
Application
NDA217677
Marketing category
NDA
Marketing start
2023-11-27
Substance
NIROGACESTAT
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Gamma Secretase Inhibitor [EPC], Gamma Secretase 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217677-001OGSIVEONIROGACESTAT HYDROBROMIDEEQ 50MG BASETABLET / ORALRLD2023-11-27
N217677-002OGSIVEONIROGACESTAT HYDROBROMIDEEQ 100MG BASETABLET / ORALRLD2024-04-04
N217677-003OGSIVEONIROGACESTAT HYDROBROMIDEEQ 150MG BASETABLET / ORALRLD, RS2024-04-04

Orange Book patents#

Current patent rows page 1 of 2 · 87 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217677-00177954472030-08-18Drug substance2023-12-01
N217677-001105900872039-08-09Drug substance2023-12-01
N217677-001107109662039-08-09U-3754Drug substance2023-12-01
N217677-001109411182039-08-09U-3754Drug substance2023-12-01
N217677-001118207482039-08-09Drug product2023-12-01
N217677-001118457322039-08-09U-3754Drug substance2023-12-20
N217677-001118846342039-08-09Drug product2024-01-31
N217677-001118846352039-08-09Drug product2024-01-31
N217677-001119052552039-08-09Drug product2024-02-21
N217677-001121163472039-08-09Drug product2024-10-17
N217677-001122971772039-08-09Drug product2025-05-19
N217677-001115043542042-07-08Drug product2023-12-01
N217677-001116125882042-07-08U-3754Drug product2023-12-01
N217677-001121102772042-07-08Drug product2024-10-17
N217677-001122342102042-07-08Drug product2025-03-14
N217677-001122470122042-07-08Drug product2025-03-14
N217677-001125995872042-07-08Drug product2026-04-30
N217677-001118076112042-09-08U-3754Drug product2023-12-01
N217677-001118447802042-09-08U-3754Drug product2023-12-20
N217677-001118722112043-05-19U-37542024-01-17
N217677-001119256192043-05-19U-37542024-03-14
N217677-001119256202043-05-19U-37542024-03-14
N217677-001119381162043-05-19U-37542024-03-27
N217677-001119510962043-05-19U-37542024-04-24
N217677-001119576622043-05-19U-37542024-04-24
N217677-001120114342043-05-19U-37542024-06-24
N217677-001120114352043-05-19U-37542024-06-24
N217677-001120362072043-05-19U-37542024-07-25
N217677-001121382462043-05-19U-37542024-11-14
N217677-00277954472030-08-18Drug substance2024-04-12
N217677-002105900872039-08-09Drug substance2024-04-12
N217677-002107109662039-08-09U-3754Drug substance2024-04-12
N217677-002109411182039-08-09U-3754Drug substance2024-04-12
N217677-002118207482039-08-09Drug product2024-04-12
N217677-002118457322039-08-09U-3754Drug substance2024-04-12
N217677-002118846342039-08-09Drug product2024-04-12
N217677-002118846352039-08-09Drug product2024-04-12
N217677-002119052552039-08-09Drug product2024-04-12
N217677-002121163472039-08-09Drug product2024-10-17
N217677-002122971772039-08-09Drug product2025-05-19
N217677-002115043542042-07-08Drug product2024-04-12
N217677-002116125882042-07-08U-3754Drug product2024-04-12
N217677-002121102772042-07-08Drug product2024-10-17
N217677-002122342102042-07-08Drug product2025-03-14
N217677-002122470122042-07-08Drug product2025-03-14
N217677-002125995872042-07-08Drug product2026-04-30
N217677-002118076112042-09-08U-3754Drug product2024-04-12
N217677-002118447802042-09-08U-3754Drug product2024-04-12
N217677-002118722112043-05-19U-37542024-04-12
N217677-002119256192043-05-19U-37542024-04-12
N217677-002119256202043-05-19U-37542024-04-12
N217677-002119381162043-05-19U-37542024-04-12
N217677-002119510962043-05-19U-37542024-04-24
N217677-002119576622043-05-19U-37542024-04-24
N217677-002120114342043-05-19U-37542024-06-24
N217677-002120114352043-05-19U-37542024-06-24
N217677-002120362072043-05-19U-37542024-07-25
N217677-002121382462043-05-19U-37542024-11-14
N217677-00377954472030-08-18Drug substance2024-04-12
N217677-003105900872039-08-09Drug substance2024-04-12
N217677-003107109662039-08-09U-3754Drug substance2024-04-12
N217677-003109411182039-08-09U-3754Drug substance2024-04-12
N217677-003118207482039-08-09Drug product2024-04-12
N217677-003118457322039-08-09U-3754Drug substance2024-04-12
N217677-003118846342039-08-09Drug product2024-04-12
N217677-003118846352039-08-09Drug product2024-04-12
N217677-003119052552039-08-09Drug product2024-04-12
N217677-003121163472039-08-09Drug product2024-10-17
N217677-003122971772039-08-09Drug product2025-05-19
N217677-003115043542042-07-08Drug product2024-04-12
N217677-003116125882042-07-08U-3754Drug product2024-04-12
N217677-003121102772042-07-08Drug product2024-10-17
N217677-003122342102042-07-08Drug product2025-03-14
N217677-003122470122042-07-08Drug product2025-03-14
N217677-003125995872042-07-08Drug product2026-04-30
N217677-003118076112042-09-08U-3754Drug product2024-04-12
N217677-003118447802042-09-08U-3754Drug product2024-04-12
N217677-003118722112043-05-19U-37542024-04-12
N217677-003119256192043-05-19U-37542024-04-12
N217677-003119256202043-05-19U-37542024-04-12

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217677-001NCE2028-11-27
N217677-001ODE-4522030-11-27
N217677-002NCE2028-11-27
N217677-002ODE*2030-11-27
N217677-003NCE2028-11-27
N217677-003ODE*2030-11-27

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 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217677-002OGSIVEOEQ 100MG BASETABLET / ORALRLD2024-04-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217677-003OGSIVEOEQ 150MG BASETABLET / ORALRLD, RS2024-04-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217677-001OGSIVEOEQ 50MG BASETABLET / ORALRLD2023-11-278072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 31 · 1,205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217677-00177954472030-08-18Drug substance2023-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001105900872039-08-09Drug substance2023-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001107109662039-08-09U-3754Drug substance2023-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001109411182039-08-09U-3754Drug substance2023-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001118207482039-08-09Drug product2023-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001118457322039-08-09U-3754Drug substance2023-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001118846342039-08-09Drug product2024-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001118846352039-08-09Drug product2024-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001119052552039-08-09Drug product2024-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001121163472039-08-09Drug product2024-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001122971772039-08-09Drug product2025-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001115043542042-07-08Drug product2023-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001116125882042-07-08U-3754Drug product2023-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001121102772042-07-08Drug product2024-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001122342102042-07-08Drug product2025-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001122470122042-07-08Drug product2025-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001118076112042-09-08U-3754Drug product2023-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001118447802042-09-08U-3754Drug product2023-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001118722112043-05-19U-37542024-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001119256192043-05-19U-37542024-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001119256202043-05-19U-37542024-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001119381162043-05-19U-37542024-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001119510962043-05-19U-37542024-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001119576622043-05-19U-37542024-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001120114342043-05-19U-37542024-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001120114352043-05-19U-37542024-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001120362072043-05-19U-37542024-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001121382462043-05-19U-37542024-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-00277954472030-08-18Drug substance2024-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002105900872039-08-09Drug substance2024-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002107109662039-08-09U-3754Drug substance2024-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002109411182039-08-09U-3754Drug substance2024-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002118207482039-08-09Drug product2024-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002118457322039-08-09U-3754Drug substance2024-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002118846342039-08-09Drug product2024-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002118846352039-08-09Drug product2024-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002119052552039-08-09Drug product2024-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002121163472039-08-09Drug product2024-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002122971772039-08-09Drug product2025-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002115043542042-07-08Drug product2024-04-12011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 94 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N217677-001NCE2028-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-001ODE-4522030-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002NCE2028-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-002ODE*2030-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-003NCE2028-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217677-003ODE*2030-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217677-001NCE2028-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217677-001ODE-4522030-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217677-002NCE2028-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217677-002ODE*2030-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217677-003NCE2028-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217677-003ODE*2030-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217677-001NCE2028-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217677-001ODE-4522030-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217677-002NCE2028-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217677-002ODE*2030-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217677-003NCE2028-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217677-003ODE*2030-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217677-001NCE2028-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217677-001ODE-4522030-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217677-002NCE2028-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217677-002ODE*2030-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217677-003NCE2028-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217677-003ODE*2030-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217677-001NCE2028-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217677-001ODE-4522030-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217677-002NCE2028-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217677-002ODE*2030-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217677-003NCE2028-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217677-003ODE*2030-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217677-001NCE2028-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217677-001ODE-4522030-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217677-002NCE2028-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217677-002ODE*2030-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217677-003NCE2028-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217677-003ODE*2030-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217677-001NCE2028-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217677-001ODE-4522030-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217677-002NCE2028-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217677-002ODE*2030-11-272680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
OGSIVEO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIROGACESTAT100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QZ62892OFJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2680360Internal RxNorm lookup
2680362Internal RxNorm lookup
2680363Internal RxNorm lookup
2680364Internal RxNorm lookup
2680366Internal RxNorm lookup
2680368Internal RxNorm lookup
2680369Internal RxNorm lookup
2680370Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f172e6ff-3190-41b0-b95a-58a7ef9e9e1eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e50401e8-eee2-4c58-bae9-e0e494a260e4Product name120231208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82448-100-14OGSIVEO14 in 1 BLISTER PACKTABLET, FILM COATED1414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82448-100-14EA - Each82448-100a4eab41b-c138-4a72-9ca8-80161844668712024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82448-100OGSIVEO (NIROGACESTAT) TABLET, FILM COATED [SPRINGWORKS THERAPEUTICS, INC.]9Current NDC, 1 package rows20241123_f172e6ff-3190-41b0-b95a-58a7ef9e9e1e.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OGSIVEONIROGACESTATSpringWorks Therapeutics, Inc.f172e6ff-3190-41b0-b95a-58a7ef9e9e1e2026-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 217677
application number: NDA217677
ndc (product): 82448-100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2680364{14 (nirogacestat 100 MG Oral Tablet [Ogsiveo]) } Pack [Ogsiveo 100 MG 7-Day]BPCKf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680370{14 (nirogacestat 150 MG Oral Tablet [Ogsiveo]) } Pack [Ogsiveo 150 MG 7-Day]BPCKf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680363{14 (nirogacestat 100 MG Oral Tablet) } PackGPCKf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680369{14 (nirogacestat 150 MG Oral Tablet) } PackGPCKf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680360nirogacestat 100 MG Oral TabletPSNf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680363nirogacestat 100 MG Tablet 7-Day 14 Count PackPSNf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680366nirogacestat 150 MG Oral TabletPSNf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680369nirogacestat 150 MG Tablet 7-Day 14 Count PackPSNf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680362Ogsiveo 100 MG Oral TabletPSNf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680364Ogsiveo 100 MG Tablet 7-Day 14 Count PackPSNf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680368Ogsiveo 150 MG Oral TabletPSNf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680370Ogsiveo 150 MG Tablet 7-Day 14 Count PackPSNf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680362nirogacestat 100 MG Oral Tablet [Ogsiveo]SBDf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680368nirogacestat 150 MG Oral Tablet [Ogsiveo]SBDf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680360nirogacestat 100 MG Oral TabletSCDf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680366nirogacestat 150 MG Oral TabletSCDf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680360nirogacestat 100 MG (equivalent to nirogacestat HBr 133.05 MG) Oral TabletSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680363nirogacestat 100 MG Tablet 7-Day 14 Count PackSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680366nirogacestat 150 MG (equivalent to nirogacestat HBr 199.574 MG) Oral TabletSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680369nirogacestat 150 MG Tablet 7-Day 14 Count PackSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680362Ogsiveo 100 MG (equivalent to nirogacestat HBr 133.05 MG) Oral TabletSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680362Ogsiveo 100 MG Oral TabletSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680364Ogsiveo 100 MG Tablet 7-Day 14 Count PackSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680368Ogsiveo 150 MG (equivalent to nirogacestat HBr 199.574 MG) Oral TabletSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680368Ogsiveo 150 MG Oral TabletSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14
2680370Ogsiveo 150 MG Tablet 7-Day 14 Count PackSYf172e6ff-3190-41b0-b95a-58a7ef9e9e1e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82448-100-148244801001414 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14) 2023-11-27NoNoCurrent