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United States · US · US:69238-1991_e9480117-8eb3-41e7-8928-1573d3d21d0e

Digoxin

Orange BookUNIISPLATC C01AA05

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

Identification

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

Packs · 2

  • ndc11
    6923819911
    100 TABLET in 1 BOTTLE (69238-1991-1)
  • ndc11
    6923819917
    1000 TABLET in 1 BOTTLE (69238-1991-7)

Annotations

UNII (FDA Substance ID)
73K4184T59
DIGOXIN
RxCUI 3407
Orange Book
A076268
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": "69238-1991_e9480117-8eb3-41e7-8928-1573d3d21d0e",
  "productndc": "69238-1991",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076268",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.125MG",
        "product_no": "001",
        "approval_date": "Jul 26, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "002",
        "approval_date": "Jul 26, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIGOXIN",
  "proprietary_name": "Digoxin",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA076268",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Digoxin",
  "start_marketing_date": "20190401",
  "active_numerator_strength": "125"
}

Related drugs

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