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United States · US · US:0054-0057_db501397-8e41-4498-8626-49c6bfd79971
Digoxin
Orange BookUNIISPLATC C01AA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC01AA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11005400574660 mL in 1 BOTTLE (0054-0057-46)
Annotations
UNII (FDA Substance ID)
73K4184T59
DIGOXIN
RxCUI 3407
Orange Book
N021648
AA
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": "0054-0057_db501397-8e41-4498-8626-49c6bfd79971",
"productndc": "0054-0057",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "021648",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "0.05MG/ML",
"product_no": "001",
"approval_date": "Aug 26, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIGOXIN",
"proprietary_name": "Digoxin",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021648",
"marketing_category": "NDA",
"nonproprietary_name": "Digoxin",
"start_marketing_date": "20040826",
"active_numerator_strength": ".05"
}Related drugs
Other records sharing ATC code C01AA05.
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