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United States · US · US:0781-3059_62ffbb27-b026-4fb2-b2a1-5c170036b8cf

Digoxin

Orange BookUNIISPLATC C01AA05

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

Identification

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

Packs · 1

  • ndc11
    0781305995
    10 AMPULE in 1 CARTON (0781-3059-95) / 2 mL in 1 AMPULE (0781-3059-72)

Annotations

UNII (FDA Substance ID)
73K4184T59
DIGOXIN
RxCUI 3407
Orange Book
A040481
AP
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": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL",
  "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": "0781-3059_62ffbb27-b026-4fb2-b2a1-5c170036b8cf",
  "productndc": "0781-3059",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "040481",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.25MG/ML",
        "product_no": "001",
        "approval_date": "Aug 21, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIGOXIN",
  "proprietary_name": "Digoxin",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA040481",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Digoxin",
  "start_marketing_date": "20030821",
  "active_numerator_strength": "250"
}

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