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
7120586400
100 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-00)
ndc11
7120586411
1000 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-11)
ndc11
7120586430
30 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-30)
ndc11
7120586455
500 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-55)
ndc11
7120586460
60 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-60)
ndc11
7120586472
120 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-72)
ndc11
7120586478
180 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-78)
ndc11
7120586490
90 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-864-90)

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": "71205-864_49b9759a-c1b9-4ebe-874b-81fb82a42755",
  "productndc": "71205-864",
  "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": "50"
}

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