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United States · US · US:50090-1299_2b35de26-dca3-4508-b0c4-f9bdea0e41da
Sotalol Hydrochloride
Orange BookUNIISPLATC C07AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC07AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11500901299060 TABLET in 1 BOTTLE (50090-1299-0)
- ndc11500901299130 TABLET in 1 BOTTLE (50090-1299-1)
- ndc11500901299290 TABLET in 1 BOTTLE (50090-1299-2)
Annotations
UNII (FDA Substance ID)
HEC37C70XX
SOTALOL HYDROCHLORIDE
RxCUI 7008
Orange Book
A076140
ABABABAB
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": {
"4614480b-b36e-4dbd-9fc0-d083890d297d": {
"match": "brand_token",
"title": "SOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]",
"spl_version": "9",
"published_date": "2026-05-21"
}
},
"productid": "50090-1299_2b35de26-dca3-4508-b0c4-f9bdea0e41da",
"productndc": "50090-1299",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076140",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "001",
"approval_date": "Sep 26, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "002",
"approval_date": "Sep 26, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "003",
"approval_date": "Sep 26, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "240MG",
"product_no": "004",
"approval_date": "Sep 26, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SOTALOL HYDROCHLORIDE",
"proprietary_name": "Sotalol Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076140",
"marketing_category": "ANDA",
"nonproprietary_name": "Sotalol Hydrochloride",
"start_marketing_date": "20030201",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C07AA07.
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