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United States · US · US:16729-293_4e68c6b7-2774-172e-e063-6294a90a0e57

Eplerenone

Orange BookUNIISPLATC C03DA04

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

Identification

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

Packs · 2

  • ndc11
    1672929310
    30 TABLET, FILM COATED in 1 BOTTLE (16729-293-10)
  • ndc11
    1672929315
    90 TABLET, FILM COATED in 1 BOTTLE (16729-293-15)

Annotations

UNII (FDA Substance ID)
6995V82D0B
EPLERENONE
RxCUI 298869
Orange Book
A206922
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": "16729-293_4e68c6b7-2774-172e-e063-6294a90a0e57",
  "productndc": "16729-293",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206922",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jul 13, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jul 13, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPLERENONE",
  "proprietary_name": "Eplerenone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206922",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eplerenone",
  "start_marketing_date": "20181009",
  "active_numerator_strength": "25"
}

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