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United States · US · US:0904-5922_fad1e8b6-cb2e-46de-8f64-22de878e8028

Digoxin

Orange BookUNIISPLATC C01AA05

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

Identification

ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeC01AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0904592261
    100 BLISTER PACK in 1 CARTON (0904-5922-61) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
73K4184T59
DIGOXIN
RxCUI 3407
Orange Book
A077002
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "73K4184T59",
    "rxcui": "3407",
    "inchikey": "LTMHDMANZUZIPE-PUGKRICDSA-N",
    "display_name": "DIGOXIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5fb1bc4e-5806-4c50-aab0-91e445d87933": {
      "match": "brand_token",
      "title": "DIGOXIN TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-05-11"
    }
  },
  "productid": "0904-5922_fad1e8b6-cb2e-46de-8f64-22de878e8028",
  "productndc": "0904-5922",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077002",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "Oct 30, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.125MG",
        "product_no": "002",
        "approval_date": "Oct 30, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIGOXIN",
  "proprietary_name": "Digoxin",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA077002",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Digoxin",
  "start_marketing_date": "20090610",
  "active_numerator_strength": "250"
}

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