🇺🇸
United States · US · US:50242-210_202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
Gavreto
Orange BookUNIISPLATC L01EX23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeL01EX23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1150242210601 BOTTLE in 1 CARTON (50242-210-60) / 60 CAPSULE in 1 BOTTLE
- ndc1150242210831 BOTTLE in 1 CARTON (50242-210-83) / 60 CAPSULE in 1 BOTTLE
- ndc1150242210901 BOTTLE in 1 CARTON (50242-210-90) / 90 CAPSULE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
1WPE73O1WV
PRALSETINIB
RxCUI 2394936
Orange Book
N213721
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1WPE73O1WV",
"rxcui": "2394936",
"inchikey": "GBLBJPZSROAGMF-RWYJCYHVSA-N",
"display_name": "PRALSETINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"16edd46e-28b8-f06d-e063-6394a90ae31b": {
"match": "brand_token",
"title": "GAVRETO (PRALSETINIB) CAPSULE [RIGEL PHARMACEUTICALS, INC.]",
"spl_version": "8",
"published_date": "2026-01-28"
}
},
"productid": "50242-210_202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c",
"productndc": "50242-210",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213721",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Sep 4, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PRALSETINIB",
"proprietary_name": "Gavreto",
"active_ingred_unit": "mg/1",
"application_number": "NDA213721",
"marketing_category": "NDA",
"nonproprietary_name": "Pralsetinib",
"start_marketing_date": "20210701",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EX23.
- PLGavretoRoche Registration GmbH
- 🇺🇸GavretoRigel Pharmaceuticals, Inc.
- DKGavretoRoche Registration GmbH
- FIGavretoBlueprint Medicines Netherlands B.V.
- NOGavretoRoche
- BEGavreto 100 mgBlueprint Medicines (Netherlands)
- 🇪🇸GAVRETO 100 MG CAPSULAS DURASBlueprint Medicines (Netherlands) B.V.
- 🇫🇷GAVRETO 100 mg, géluleBLUEPRINT MEDICINES (PAYS-BAS))
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