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United States · US · US:60505-0082_7e1fd07e-45aa-ef32-da1b-c81f6961f216
Sotalol Hydrochloride
Orange BookUNIISPLATC C07AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeC07AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116050500820100 TABLET in 1 BOTTLE (60505-0082-0)
- ndc1160505008211000 TABLET in 1 BOTTLE (60505-0082-1)
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": "60505-0082_7e1fd07e-45aa-ef32-da1b-c81f6961f216",
"productndc": "60505-0082",
"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": "240"
}Related drugs
Other records sharing ATC code C07AA07.
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