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United States · US · US:42806-039_666cb1d9-ec1f-453a-be4f-fafa2b67c1fd

Betaxolol

Orange BookUNIISPLATC S01ED52

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEpic Pharma LLC
CountryUS (United States)
ATC codeS01ED52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4280603901
    100 TABLET, FILM COATED in 1 BOTTLE (42806-039-01)
  • ndc11
    4280603910
    1000 TABLET, FILM COATED in 1 BOTTLE (42806-039-10)

Annotations

UNII (FDA Substance ID)
6X97D2XT0O
BETAXOLOL HYDROCHLORIDE
RxCUI 142144
Orange Book
A075541
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6X97D2XT0O",
    "rxcui": "142144",
    "inchikey": "CHDPSNLJFOQTRK-UHFFFAOYSA-N",
    "display_name": "BETAXOLOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bf716efe-0a9f-43b1-9d8a-c69330b82e18": {
      "match": "brand_token",
      "title": "BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]",
      "spl_version": "12",
      "published_date": "2024-12-23"
    }
  },
  "productid": "42806-039_666cb1d9-ec1f-453a-be4f-fafa2b67c1fd",
  "productndc": "42806-039",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075541",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 22, 1999"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Oct 22, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BETAXOLOL HYDROCHLORIDE",
  "proprietary_name": "Betaxolol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075541",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Betaxolol",
  "start_marketing_date": "20100720",
  "active_numerator_strength": "20"
}

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