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United States · US · US:70954-200_ee465d1a-f5ee-477b-b20e-3ce8705e7472
Digoxin
Orange BookUNIISPLATC C01AA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC01AA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117095420010100 TABLET in 1 BOTTLE (70954-200-10)
Annotations
UNII (FDA Substance ID)
73K4184T59
DIGOXIN
RxCUI 3407
Orange Book
A215307
ABABAB
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": "70954-200_ee465d1a-f5ee-477b-b20e-3ce8705e7472",
"productndc": "70954-200",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215307",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.125MG",
"product_no": "001",
"approval_date": "Nov 22, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "002",
"approval_date": "Nov 22, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.0625MG",
"product_no": "003",
"approval_date": "Aug 25, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIGOXIN",
"proprietary_name": "Digoxin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215307",
"marketing_category": "ANDA",
"nonproprietary_name": "Digoxin",
"start_marketing_date": "20220825",
"active_numerator_strength": ".0625"
}Related drugs
Other records sharing ATC code C01AA05.
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