Sotalol Hydrochloride

Orange BookUNIISPLATC C07AA07

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

Identification

ManufacturerAvPAK

CountryUS (United States)

ATC codeC07AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5026872415
50 BLISTER PACK in 1 BOX (50268-724-15) / 1 TABLET in 1 BLISTER PACK (50268-724-11)

Annotations

UNII (FDA Substance ID)

HEC37C70XX

SOTALOL HYDROCHLORIDE

RxCUI 7008

Orange Book

A076140

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": "50268-724_47fc0908-1c7a-abc6-e063-6294a90a20b2",
  "productndc": "50268-724",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076140",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "001",
        "approval_date": "Sep 26, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "002",
        "approval_date": "Sep 26, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "003",
        "approval_date": "Sep 26, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "004",
        "approval_date": "Sep 26, 2002"
      }
    ],
    "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": "ANDA076140",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sotalol Hydrochloride",
  "start_marketing_date": "20210304",
  "active_numerator_strength": "80"
}

Related drugs

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