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United States · US · US:76385-116_fe9ac463-547d-4917-a98e-61f1c0fe38f1
Sotalol
Orange BookUNIISPLATC C07AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUNICHEM PHARMACEUTICALS (USA), INC.
CountryUS (United States)
ATC codeC07AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117638511601100 TABLET in 1 BOTTLE, PLASTIC (76385-116-01)
- ndc117638511650500 TABLET in 1 BOTTLE, PLASTIC (76385-116-50)
Annotations
UNII (FDA Substance ID)
HEC37C70XX
SOTALOL HYDROCHLORIDE
RxCUI 7008
Orange Book
A207428
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": "76385-116_fe9ac463-547d-4917-a98e-61f1c0fe38f1",
"productndc": "76385-116",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207428",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "001",
"approval_date": "Oct 21, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "002",
"approval_date": "Oct 21, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "003",
"approval_date": "Oct 21, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SOTALOL HYDROCHLORIDE",
"proprietary_name": "Sotalol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207428",
"marketing_category": "ANDA",
"nonproprietary_name": "Sotalol Hydrochloride",
"start_marketing_date": "20171206",
"active_numerator_strength": "160"
}Related drugs
Other records sharing ATC code C07AA07.
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