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United States · US · US:60631-040_2f63b0e8-977a-4d22-9550-29ad1926a9de
Edarbi
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11606310403030 TABLET in 1 BOTTLE (60631-040-30)
- ndc1160631040777 TABLET in 1 BOTTLE (60631-040-77)
Annotations
Orange Book
N200796
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"52b27c75-9f5a-4816-bafd-dace9d7d2063": {
"match": "brand_token",
"title": "EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "17",
"published_date": "2024-01-31"
}
},
"productid": "60631-040_2f63b0e8-977a-4d22-9550-29ad1926a9de",
"productndc": "60631-040",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "200796",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 40MG MEDOXOMIL",
"product_no": "001",
"approval_date": "Feb 25, 2011"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 80MG MEDOXOMIL",
"product_no": "002",
"approval_date": "Feb 25, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZILSARTAN KAMEDOXOMIL",
"proprietary_name": "Edarbi",
"active_ingred_unit": "mg/1",
"application_number": "NDA200796",
"marketing_category": "NDA",
"nonproprietary_name": "Azilsartan kamedoxomil",
"start_marketing_date": "20130201",
"active_numerator_strength": "40"
}Access this data programmatically
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