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United States · US · US:24658-701_7ee988e7-153d-4d55-b4ec-1a8da8f78f1d

Betaxolol

Orange BookUNIISPLATC S01ED52

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

Identification

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

Packs · 1

  • ndc11
    2465870101
    100 TABLET, FILM COATED in 1 BOTTLE (24658-701-01)

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": "24658-701_7ee988e7-153d-4d55-b4ec-1a8da8f78f1d",
  "productndc": "24658-701",
  "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": "20160822",
  "active_numerator_strength": "20"
}

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