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United States · US · US:82448-100_39192daa-3e54-4741-adad-7d3742860396
OGSIVEO
Orange BookUNIISPLATC L01XX81
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSpringWorks Therapeutics, Inc.
CountryUS (United States)
ATC codeL01XX81
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11824481001414 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14)
Annotations
UNII (FDA Substance ID)
QZ62892OFJ
NIROGACESTAT
Orange Book
N217677
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QZ62892OFJ",
"rxcui": null,
"inchikey": "VFCRKLWBYMDAED-REWPJTCUSA-N",
"display_name": "NIROGACESTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f172e6ff-3190-41b0-b95a-58a7ef9e9e1e": {
"match": "brand_token",
"title": "OGSIVEO (NIROGACESTAT) TABLET, FILM COATED [SPRINGWORKS THERAPEUTICS, INC.]",
"spl_version": "14",
"published_date": "2026-03-26"
}
},
"productid": "82448-100_39192daa-3e54-4741-adad-7d3742860396",
"productndc": "82448-100",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217677",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Nov 27, 2023"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Apr 4, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "003",
"approval_date": "Apr 4, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIROGACESTAT",
"proprietary_name": "OGSIVEO",
"active_ingred_unit": "mg/1",
"application_number": "NDA217677",
"marketing_category": "NDA",
"nonproprietary_name": "nirogacestat",
"start_marketing_date": "20231127",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01XX81.
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