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United States · US · US:69724-112_d155f318-ecbf-4392-90a1-4409c5b8d13f
Sotalol hydrochloride
Orange BookUNIISPLATC C07AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerALTATHERA Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC07AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169724112101 VIAL in 1 CARTON (69724-112-10) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
HEC37C70XX
SOTALOL HYDROCHLORIDE
RxCUI 7008
Orange Book
N022306
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": "INTRAVENOUS",
"spl_meta": {
"4614480b-b36e-4dbd-9fc0-d083890d297d": {
"match": "brand_token",
"title": "SOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]",
"spl_version": "9",
"published_date": "2026-05-21"
}
},
"productid": "69724-112_d155f318-ecbf-4392-90a1-4409c5b8d13f",
"productndc": "69724-112",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "022306",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MG/10ML (15MG/ML)",
"product_no": "001",
"approval_date": "Jul 2, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SOTALOL HYDROCHLORIDE",
"proprietary_name": "Sotalol hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022306",
"marketing_category": "NDA",
"nonproprietary_name": "Sotalol hydrochloride",
"start_marketing_date": "20151015",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code C07AA07.
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