Sotalol Hydrochloride

Orange BookUNIISPLATC C07AA07

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeC07AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0093106301
100 TABLET in 1 BOTTLE (0093-1063-01)

Annotations

UNII (FDA Substance ID)

HEC37C70XX

SOTALOL HYDROCHLORIDE

RxCUI 7008

Orange Book

A075429

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": "0093-1063_b0c7f185-187e-443c-9ca8-7ff9658bf713",
  "productndc": "0093-1063",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075429",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "001",
        "approval_date": "May 1, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "002",
        "approval_date": "May 1, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "003",
        "approval_date": "May 1, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "004",
        "approval_date": "May 1, 2000"
      }
    ],
    "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": "ANDA075429",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sotalol Hydrochloride",
  "start_marketing_date": "20000505",
  "active_numerator_strength": "240"
}

Related drugs

Other records sharing ATC code C07AA07.

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