Sotalol Hydrochloride

Orange BookUNIISPLATC C07AA07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeC07AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
8280497400
100 TABLET in 1 BOTTLE (82804-974-00)
ndc11
8280497411
1000 TABLET in 1 BOTTLE (82804-974-11)
ndc11
8280497430
30 TABLET in 1 BOTTLE (82804-974-30)
ndc11
8280497455
500 TABLET in 1 BOTTLE (82804-974-55)
ndc11
8280497460
60 TABLET in 1 BOTTLE (82804-974-60)
ndc11
8280497472
120 TABLET in 1 BOTTLE (82804-974-72)
ndc11
8280497490
90 TABLET in 1 BOTTLE (82804-974-90)

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": "82804-974_959dc952-bed6-4538-a1a6-61ed10c06be4",
  "productndc": "82804-974",
  "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

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