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United States · US · US:82928-300_16d31d7e-dc21-4cdb-92b8-56919827a192
EKTERLY
Orange BookUNIISPLATC B06AC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKalVista Pharmaceuticals Ltd
CountryUS (United States)
ATC codeB06AC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1182928300044 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01)
Annotations
UNII (FDA Substance ID)
O5ZD2TU2B7
SEBETRALSTAT
Orange Book
N219301
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "O5ZD2TU2B7",
"rxcui": null,
"inchikey": "KGMPDQIYDKKXRD-UHFFFAOYSA-N",
"display_name": "SEBETRALSTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1d145e2f-8e7e-2e90-e063-6294a90a4449": {
"match": "brand_token",
"title": "EKTERLY (SEBETRALSTAT) TABLET [KALVISTA PHARMACEUTICALS LTD]",
"spl_version": "4",
"published_date": "2026-05-28"
}
},
"productid": "82928-300_16d31d7e-dc21-4cdb-92b8-56919827a192",
"productndc": "82928-300",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "219301",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "300MG",
"product_no": "001",
"approval_date": "Jul 3, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SEBETRALSTAT",
"proprietary_name": "EKTERLY",
"active_ingred_unit": "mg/1",
"application_number": "NDA219301",
"marketing_category": "NDA",
"nonproprietary_name": "sebetralstat",
"start_marketing_date": "20250703",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code B06AC08.
- FIEkterlyKalvista Pharmaceuticals (Ireland) Limited
- ISEkterlyKalvista Pharmaceuticals (Ireland) Limited
- CZEKTERLYKalVista Pharmaceuticals (Ireland) Ltd., Dublin
- CZEKTERLYKalVista Pharmaceuticals (Ireland) Ltd., Dublin
- BEEkterly 300 mgKalvista Pharmaceuticals (Ireland)
- IEEkterly 300 mg film-coated tabletsKalvista Pharmaceuticals (Ireland) Limited
- NLEkterly 300 mg filmomhulde tablettenKalvista Pharmaceuticals (Ireland) Limited
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