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 · 8

ndc11
8280495100
100 TABLET in 1 BOTTLE (82804-951-00)
ndc11
8280495111
1000 TABLET in 1 BOTTLE (82804-951-11)
ndc11
8280495130
30 TABLET in 1 BOTTLE (82804-951-30)
ndc11
8280495155
500 TABLET in 1 BOTTLE (82804-951-55)
ndc11
8280495160
60 TABLET in 1 BOTTLE (82804-951-60)
ndc11
8280495172
120 TABLET in 1 BOTTLE (82804-951-72)
ndc11
8280495190
90 TABLET in 1 BOTTLE (82804-951-90)
ndc11
8280495196
300 TABLET in 1 BOTTLE (82804-951-96)

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": "82804-951_10b7b81d-9ce7-4025-8559-fdfa41c8b146",
  "productndc": "82804-951",
  "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": "120"
}

Related drugs

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