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United States · US · US:0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a
FABHALTA
Orange BookUNIISPLATC L04AJ08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL04AJ08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11007811892060 CAPSULE in 1 BOTTLE (0078-1189-20)
Annotations
UNII (FDA Substance ID)
XW5CK7C6YH
IPTACOPAN HYDROCHLORIDE
Orange Book
N218276
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "XW5CK7C6YH",
"rxcui": null,
"inchikey": "JUWBBUFSAGEROP-VVJLZRNGSA-N",
"display_name": "IPTACOPAN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a76b5845-6e21-4d3b-ad07-cd8df1b60bee": {
"match": "brand_token",
"title": "FABHALTA (IPTACOPAN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]",
"spl_version": "4",
"published_date": "2025-03-24"
}
},
"productid": "0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a",
"productndc": "0078-1189",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218276",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "001",
"approval_date": "Dec 5, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IPTACOPAN HYDROCHLORIDE",
"proprietary_name": "FABHALTA",
"active_ingred_unit": "mg/1",
"application_number": "NDA218276",
"marketing_category": "NDA",
"nonproprietary_name": "iptacopan",
"start_marketing_date": "20231205",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code L04AJ08.
- NOFabhaltaNovartis Europharm Limited
- 🇨🇭FabhaltaNovartis Pharma Schweiz AG
- PLFabhaltaNovartis Europharm Limited
- CZFABHALTANovartis Europharm Limited, Dublin
- DKFABHALTANovartis Europharm Limited
- CZFABHALTANovartis Europharm Limited, Dublin
- CZFABHALTANovartis Europharm Limited, Dublin
- CAFABHALTANOVARTIS PHARMACEUTICALS CANADA INC
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