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United States · US · US:0078-1483_9e44a793-9940-4ae3-9fe6-0f901afa37e0
RHAPSIDO
Orange BookUNIISPLATC L04AA60
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL04AA60
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11007814832060 TABLET in 1 BOTTLE (0078-1483-20)
- ndc1100781483922 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE
- ndc11007814839330 TABLET in 1 BOTTLE (0078-1483-93)
Annotations
UNII (FDA Substance ID)
I7MVZ8HDNU
REMIBRUTINIB
Orange Book
N218436
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "I7MVZ8HDNU",
"rxcui": null,
"inchikey": "CUABMPOJOBCXJI-UHFFFAOYSA-N",
"display_name": "REMIBRUTINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e5e89bff-6ced-4165-acc5-fb13136b3a3d": {
"match": "brand_token",
"title": "RHAPSIDO (REMIBRUTINIB) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "2",
"published_date": "2026-03-24"
}
},
"productid": "0078-1483_9e44a793-9940-4ae3-9fe6-0f901afa37e0",
"productndc": "0078-1483",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218436",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Sep 30, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "REMIBRUTINIB",
"proprietary_name": "RHAPSIDO",
"active_ingred_unit": "mg/1",
"application_number": "NDA218436",
"marketing_category": "NDA",
"nonproprietary_name": "remibrutinib",
"start_marketing_date": "20250930",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code L04AA60.
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