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United States · US · US:60631-412_26b92714-c5ea-943d-e063-6394a90a8341
Edarbyclor
Orange BookSPLATC C03BA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
CountryUS (United States)
ATC codeC03BA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11606314123030 TABLET in 1 BOTTLE (60631-412-30)
Annotations
Orange Book
N202331
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"10566939-c8b1-18a1-e063-6294a90a7601": {
"match": "brand_token",
"title": "EDARBYCLOR (AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE) TABLET [PHARMA PACKAGING SOLUTIONS, LLC DBA TJOAPACK LLC]",
"spl_version": "2",
"published_date": "2025-07-25"
}
},
"productid": "60631-412_26b92714-c5ea-943d-e063-6394a90a8341",
"productndc": "60631-412",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202331",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 40MG MEDOXOMIL;12.5MG",
"product_no": "001",
"approval_date": "Dec 20, 2011"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 40MG MEDOXOMIL;25MG",
"product_no": "002",
"approval_date": "Dec 20, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE",
"proprietary_name": "Edarbyclor",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA202331",
"marketing_category": "NDA",
"nonproprietary_name": "Azilsartan kamedoxomil and chlorthalidone",
"start_marketing_date": "20130201",
"active_numerator_strength": "40; 12.5"
}Related drugs
Other records sharing ATC code C03BA.
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