Eplerenone

Orange BookUNIISPLATC C03DA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAvKARE

CountryUS (United States)

ATC codeC03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4229145590
90 TABLET, COATED in 1 BOTTLE (42291-455-90)

Annotations

UNII (FDA Substance ID)

6995V82D0B

EPLERENONE

RxCUI 298869

Orange Book

A207842

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": "42291-455_485d3fe4-eadd-a4dc-e063-6294a90ab9f0",
  "productndc": "42291-455",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "207842",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Oct 25, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Oct 25, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPLERENONE",
  "proprietary_name": "Eplerenone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207842",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eplerenone",
  "start_marketing_date": "20220303",
  "active_numerator_strength": "50"
}

Related drugs

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