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United States · US · US:50242-202_a0597961-b4b9-47ec-961a-919fa9ffba95
EVRYSDI
Orange BookUNIISPLATC M09AX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeM09AX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150242202011 BOTTLE, PLASTIC in 1 CARTON (50242-202-01) / 30 TABLET in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
76RS4S2ET1
RISDIPLAM
RxCUI 2390935
Orange Book
N219285
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "76RS4S2ET1",
"rxcui": "2390935",
"inchikey": "ASKZRYGFUPSJPN-UHFFFAOYSA-N",
"display_name": "RISDIPLAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"eceb9a99-7191-4be5-87c3-0102707cf98e": {
"match": "brand_token",
"title": "EVRYSDI (RISDIPLAM) POWDER, FOR SOLUTION EVRYSDI (RISDIPLAM) TABLET [GENENTECH, INC.]",
"spl_version": "26",
"published_date": "2026-02-26"
}
},
"productid": "50242-202_a0597961-b4b9-47ec-961a-919fa9ffba95",
"productndc": "50242-202",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "219285",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 11, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RISDIPLAM",
"proprietary_name": "EVRYSDI",
"active_ingred_unit": "mg/1",
"application_number": "NDA219285",
"marketing_category": "NDA",
"nonproprietary_name": "Risdiplam",
"start_marketing_date": "20250211",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M09AX10.
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