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United States · US · US:70515-261_415f97e2-9ce0-b282-e063-6394a90ab0a8
LANOXIN
Orange BookUNIISPLATC C01AA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCovis Pharma US, Inc
CountryUS (United States)
ATC codeC01AA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705152611010 VIAL in 1 BOX (70515-261-10) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
73K4184T59
DIGOXIN
RxCUI 3407
Orange Book
N009330
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",
"spl_meta": {
"9ec84cac-6ecc-43dc-8006-6ccc029e2707": {
"match": "brand_token",
"title": "LANOXIN (DIGOXIN) INJECTION, SOLUTION [COVIS PHARMA US, INC]",
"spl_version": "10",
"published_date": "2025-11-17"
}
},
"productid": "70515-261_415f97e2-9ce0-b282-e063-6394a90ab0a8",
"productndc": "70515-261",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "009330",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "0.25MG/ML",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.1MG/ML",
"product_no": "004",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIGOXIN",
"proprietary_name": "LANOXIN",
"active_ingred_unit": "ug/mL",
"application_number": "NDA009330",
"marketing_category": "NDA",
"nonproprietary_name": "digoxin",
"start_marketing_date": "20191029",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code C01AA05.
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