🇺🇸
United States · US · US:71332-006_af2c2115-cb7d-4679-935a-c2200487b965
Gavreto
Orange BookUNIISPLATC L01EX23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRigel Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01EX23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117133200612120 CAPSULE in 1 BOTTLE (71332-006-12)
- ndc11713320066060 CAPSULE in 1 BOTTLE (71332-006-60)
- ndc11713320069090 CAPSULE in 1 BOTTLE (71332-006-90)
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": "71332-006_af2c2115-cb7d-4679-935a-c2200487b965",
"productndc": "71332-006",
"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": "20240624",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EX23.
- NOGavretoRoche
- PLGavretoRoche Registration GmbH
- DKGavretoRoche Registration GmbH
- FIGavretoBlueprint Medicines Netherlands B.V.
- 🇺🇸GavretoGenentech, Inc.
- BEGavreto 100 mgBlueprint Medicines (Netherlands)
- 🇫🇷GAVRETO 100 mg, géluleBLUEPRINT MEDICINES (PAYS-BAS))
- GBGavreto 100mg capsulesBlueprint Medicines (UK) Ltd
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