BETAPACE

Orange BookUNIISPLATC C07AA07

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

Identification

ManufacturerLegacy Pharma USA, Inc.

CountryUS (United States)

ATC codeC07AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8310700710
100 TABLET in 1 BOTTLE (83107-007-10)

Annotations

UNII (FDA Substance ID)

HEC37C70XX

SOTALOL HYDROCHLORIDE

RxCUI 7008

Orange Book

N019865

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": {
    "a6a7702f-36c9-45db-b640-453dc324baee": {
      "match": "brand_token",
      "title": "BETAPACE (SOTALOL HYDROCHLORIDE) TABLET BETAPACE AF (SOTALOL HYDROCHLORIDE) TABLET [LEGACY PHARMA USA, INC.]",
      "spl_version": "2",
      "published_date": "2024-12-20"
    }
  },
  "productid": "83107-007_fcc2fc9c-87b2-4f9f-8d4d-b1f10214884e",
  "productndc": "83107-007",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019865",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "001",
        "approval_date": "Oct 30, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "002",
        "approval_date": "Oct 30, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Oct 30, 1992"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "320MG",
        "product_no": "004",
        "approval_date": "Oct 30, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "005",
        "approval_date": "Apr 20, 1994"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SOTALOL HYDROCHLORIDE",
  "proprietary_name": "BETAPACE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019865",
  "marketing_category": "NDA",
  "nonproprietary_name": "sotalol hydrochloride",
  "start_marketing_date": "20160901",
  "active_numerator_strength": "160"
}

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