EPLERENONE

Orange BookUNIISPLATC C03DA04

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

Identification

ManufacturerBreckenridge Pharmaceutical, Inc.

CountryUS (United States)

ATC codeC03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5199187711
10 BLISTER PACK in 1 CARTON (51991-877-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (51991-877-99)
ndc11
5199187733
30 TABLET, FILM COATED in 1 BOTTLE (51991-877-33)
ndc11
5199187790
90 TABLET, FILM COATED in 1 BOTTLE (51991-877-90)

Annotations

UNII (FDA Substance ID)

6995V82D0B

EPLERENONE

RxCUI 298869

Orange Book

A208283

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": "51991-877_546c0ded-8c22-4840-b369-a3029dedc299",
  "productndc": "51991-877",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208283",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Sep 14, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Sep 14, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPLERENONE",
  "proprietary_name": "EPLERENONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208283",
  "marketing_category": "ANDA",
  "nonproprietary_name": "EPLERENONE",
  "start_marketing_date": "20180918",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code C03DA04.

Access this data programmatically

Query EPLERENONE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs