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United States · US · US:71335-1917_7da2dbe1-dd39-487c-99ee-59ff2fae4eb2
Sotalol Hydrochloride
Orange BookUNIISPLATC C07AA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC07AA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11713351917160 TABLET in 1 BOTTLE (71335-1917-1)
- ndc11713351917230 TABLET in 1 BOTTLE (71335-1917-2)
- ndc117133519173100 TABLET in 1 BOTTLE (71335-1917-3)
- ndc11713351917490 TABLET in 1 BOTTLE (71335-1917-4)
Annotations
UNII (FDA Substance ID)
HEC37C70XX
SOTALOL HYDROCHLORIDE
RxCUI 7008
Orange Book
A075563
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": "71335-1917_7da2dbe1-dd39-487c-99ee-59ff2fae4eb2",
"productndc": "71335-1917",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075563",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "001",
"approval_date": "Nov 7, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "002",
"approval_date": "Nov 7, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "160MG",
"product_no": "003",
"approval_date": "Nov 7, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "240MG",
"product_no": "004",
"approval_date": "Nov 7, 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": "ANDA075563",
"marketing_category": "ANDA",
"nonproprietary_name": "Sotalol Hydrochloride",
"start_marketing_date": "20200724",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C07AA07.
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