EPLERENONE

Orange BookUNIISPLATC C03DA04

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
3172205030
30 TABLET, FILM COATED in 1 BOTTLE (31722-050-30)
ndc11
3172205090
90 TABLET, FILM COATED in 1 BOTTLE (31722-050-90)

Annotations

UNII (FDA Substance ID)

6995V82D0B

EPLERENONE

RxCUI 298869

Orange Book

A213812

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": "31722-050_fe285cf1-1e78-943b-e053-6394a90a760d",
  "productndc": "31722-050",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213812",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jun 2, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jun 2, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPLERENONE",
  "proprietary_name": "EPLERENONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213812",
  "marketing_category": "ANDA",
  "nonproprietary_name": "EPLERENONE",
  "start_marketing_date": "20230602",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code C03DA04.

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