Inspra

Orange BookUNIISPLATC C03DA04

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeC03DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5815114393
30 TABLET, FILM COATED in 1 BOTTLE (58151-143-93)

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": {
    "1a52bedc-8e2c-4116-a296-a87770676b4a": {
      "match": "brand_token",
      "title": "INSPRA (EPLERENONE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]",
      "spl_version": "6",
      "published_date": "2026-02-06"
    }
  },
  "productid": "58151-143_77698b88-befe-44ae-b67d-03c56dcbbdf6",
  "productndc": "58151-143",
  "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": "Inspra",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021437",
  "marketing_category": "NDA",
  "nonproprietary_name": "eplerenone",
  "start_marketing_date": "20240917",
  "active_numerator_strength": "50"
}

Related drugs

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