Sotalol Hydrochloride

Orange BookUNIISPLATC C07AA07

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC07AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7161072330
30 TABLET in 1 BOTTLE (71610-723-30)
ndc11
7161072360
90 TABLET in 1 BOTTLE (71610-723-60)
ndc11
7161072380
180 TABLET in 1 BOTTLE (71610-723-80)

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": "71610-723_15689e23-7236-4cfd-8ab4-9b8450b82299",
  "productndc": "71610-723",
  "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": "20020926",
  "active_numerator_strength": "80"
}

Related drugs

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