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United States · US · US:59762-1108_b4bf45ee-6524-4a9d-9d7d-91886e32ee72

Eplerenone

Orange BookUNIISPLATC C03DA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC03DA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5976211081
    30 TABLET, FILM COATED in 1 BOTTLE (59762-1108-1)
  • ndc11
    5976211082
    90 TABLET, FILM COATED in 1 BOTTLE (59762-1108-2)

Annotations

UNII (FDA Substance ID)
6995V82D0B
EPLERENONE
RxCUI 298869
Orange Book
N021437
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": "59762-1108_b4bf45ee-6524-4a9d-9d7d-91886e32ee72",
  "productndc": "59762-1108",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021437",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Sep 27, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Sep 27, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Sep 27, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPLERENONE",
  "proprietary_name": "Eplerenone",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021437",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "eplerenone",
  "start_marketing_date": "20241114",
  "active_numerator_strength": "50"
}

Related drugs

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