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United States · US · US:24338-530_73961d33-7149-49f3-8386-91f1b1758ca5
SOTYLIZE
Orange BookUNIISPLATC C07AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC07AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc112433853025250 mL in 1 BOTTLE (24338-530-25)
- ndc112433853048480 mL in 1 BOTTLE (24338-530-48)
Annotations
UNII (FDA Substance ID)
HEC37C70XX
SOTALOL HYDROCHLORIDE
RxCUI 7008
Orange Book
N205108
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HEC37C70XX",
"rxcui": "7008",
"inchikey": "VIDRYROWYFWGSY-UHFFFAOYSA-N",
"display_name": "SOTALOL HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1f33f900-0777-4a92-a7f7-00cf3d57d95c": {
"match": "brand_token",
"title": "SOTYLIZE (SOTALOL HYDROCHLORIDE) SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "6",
"published_date": "2024-01-30"
}
},
"productid": "24338-530_73961d33-7149-49f3-8386-91f1b1758ca5",
"productndc": "24338-530",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "205108",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG/ML (5MG/ML)",
"product_no": "001",
"approval_date": "Oct 22, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SOTALOL HYDROCHLORIDE",
"proprietary_name": "SOTYLIZE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA205108",
"marketing_category": "NDA",
"nonproprietary_name": "SOTALOL HYDROCHLORIDE",
"start_marketing_date": "20150301",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C07AA07.
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