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United States · US · US:16729-293_4e68c6b7-2774-172e-e063-6294a90a0e57
Eplerenone
Orange BookUNIISPLATC C03DA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare, Inc.
CountryUS (United States)
ATC codeC03DA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11167292931030 TABLET, FILM COATED in 1 BOTTLE (16729-293-10)
- ndc11167292931590 TABLET, FILM COATED in 1 BOTTLE (16729-293-15)
Annotations
UNII (FDA Substance ID)
6995V82D0B
EPLERENONE
RxCUI 298869
Orange Book
A206922
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6995V82D0B",
"rxcui": "298869",
"inchikey": "JUKPWJGBANNWMW-VWBFHTRKSA-N",
"display_name": "EPLERENONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e2a51c12-bdc2-4b3b-8e9e-bf363c2817ed": {
"match": "brand_token",
"title": "EPLERENONE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]",
"spl_version": "8",
"published_date": "2026-05-07"
}
},
"productid": "16729-293_4e68c6b7-2774-172e-e063-6294a90a0e57",
"productndc": "16729-293",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206922",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Jul 13, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Jul 13, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPLERENONE",
"proprietary_name": "Eplerenone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206922",
"marketing_category": "ANDA",
"nonproprietary_name": "Eplerenone",
"start_marketing_date": "20181009",
"active_numerator_strength": "25"
}Related drugs
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- CZAPLERIAKrka, d.d., Novo mesto, Novo mesto
- CZAPLERIAKrka, d.d., Novo mesto, Novo mesto
- CZAPLERIAKrka, d.d., Novo mesto, Novo mesto
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- CZAPLERIAKrka, d.d., Novo mesto, Novo mesto
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