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

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 Identifiers#

Field, Values table
FieldValues
UniiQZ62892OFJ
Rxcui2680360, 2680362, 2680363, 2680364, 2680366, 2680368, 2680369, 2680370

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

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) 2023-11-27NoNoHistorical