Eplerenone

Orange BookUNIISPLATC C03DA04

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeC03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7120586300
100 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-00)
ndc11
7120586311
1000 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-11)
ndc11
7120586330
30 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-30)
ndc11
7120586355
500 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-55)
ndc11
7120586360
60 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-60)
ndc11
7120586372
120 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-72)
ndc11
7120586378
180 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-78)
ndc11
7120586390
90 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-90)

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": "71205-863_49b9759a-c1b9-4ebe-874b-81fb82a42755",
  "productndc": "71205-863",
  "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": "20211108",
  "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