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United States · US · US:61314-245_c30e555b-1a79-4c3e-b79d-8c1d950fd832

Betaxolol Hydrochloride

Orange BookUNIISPLATC S01ED52

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeS01ED52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6131424501
    1 BOTTLE, PLASTIC in 1 CARTON (61314-245-01) / 5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    6131424502
    1 BOTTLE, PLASTIC in 1 CARTON (61314-245-02) / 15 mL in 1 BOTTLE, PLASTIC
  • ndc11
    6131424503
    1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
6X97D2XT0O
BETAXOLOL HYDROCHLORIDE
RxCUI 142144
Orange Book
N019270
AT
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": "OPHTHALMIC",
  "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": "61314-245_c30e555b-1a79-4c3e-b79d-8c1d950fd832",
  "productndc": "61314-245",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "019270",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Aug 30, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BETAXOLOL HYDROCHLORIDE",
  "proprietary_name": "Betaxolol Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019270",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Betaxolol Hydrochloride",
  "start_marketing_date": "20000515",
  "active_numerator_strength": "5.6"
}

Related drugs

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