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United States · US · US:71610-074_0e87b445-6112-4dfa-9961-95beb8f7eb82
Sotalol Hydrochloride
Orange BookUNIISPLATC C07AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC07AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11716100743030 TABLET in 1 BOTTLE, PLASTIC (71610-074-30)
- ndc11716100746090 TABLET in 1 BOTTLE, PLASTIC (71610-074-60)
Annotations
UNII (FDA Substance ID)
HEC37C70XX
SOTALOL HYDROCHLORIDE
RxCUI 7008
Orange Book
A076214
ABABAB
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": "71610-074_0e87b445-6112-4dfa-9961-95beb8f7eb82",
"productndc": "71610-074",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076214",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "001",
"approval_date": "Aug 27, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "002",
"approval_date": "Aug 27, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "003",
"approval_date": "Aug 27, 2003"
}
],
"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": "ANDA076214",
"marketing_category": "ANDA",
"nonproprietary_name": "Sotalol Hydrochloride",
"start_marketing_date": "20030909",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C07AA07.
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