🇺🇸
United States · US · US:50242-079_dd6ab36d-21fa-4513-a9d1-0867ca4420e8
Itovebi
Orange BookUNIISPLATC L01EM
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeL01EM
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150242079081 BOTTLE in 1 CARTON (50242-079-08) / 28 TABLET, FILM COATED in 1 BOTTLE
- ndc1150242079861 BOTTLE in 1 CARTON (50242-079-86) / 28 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
L4C1UY2NYH
INAVOLISIB
Orange Book
N219249
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "L4C1UY2NYH",
"rxcui": null,
"inchikey": "SGEUNORSOZVTOL-CABZTGNLSA-N",
"display_name": "INAVOLISIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"5de59f5b-e5db-410f-b692-658686ef4107": {
"match": "brand_token",
"title": "ITOVEBI (INAVOLISIB) TABLET, FILM COATED [GENENTECH, INC.]",
"spl_version": "10",
"published_date": "2026-04-28"
}
},
"productid": "50242-079_dd6ab36d-21fa-4513-a9d1-0867ca4420e8",
"productndc": "50242-079",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "219249",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "3MG",
"product_no": "001",
"approval_date": "Oct 10, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "9MG",
"product_no": "002",
"approval_date": "Oct 10, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "INAVOLISIB",
"proprietary_name": "Itovebi",
"active_ingred_unit": "mg/1",
"application_number": "NDA219249",
"marketing_category": "NDA",
"nonproprietary_name": "Inavolisib",
"start_marketing_date": "20241014",
"active_numerator_strength": "9"
}Related drugs
Other records sharing ATC code L01EM.
- 🇺🇸ItovebiGenentech, Inc.
- 🇪🇸ITOVEBI 3 MG COMPRIMIDOS RECUBIERTOS CON PELICULARoche Registration Gmbh
- NLItovebi 3 mg filmomhulde tablettenRoche Registration GmbH
- 🇫🇷ITOVEBI 3 mg, comprimé pelliculéROCHE REGISTRATION (ALLEMAGNE)
- GBItovebi 3mg tabletsRoche Products Ltd
- 🇪🇸ITOVEBI 9 MG COMPRIMIDOS RECUBIERTOS CON PELICULARoche Registration Gmbh
- NLItovebi 9 mg filmomhulde tablettenRoche Registration GmbH
- 🇫🇷ITOVEBI 9 mg, comprimé pelliculéROCHE REGISTRATION (ALLEMAGNE)
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