ETHACRYNATE SODIUM

Orange BookUNIISPLATC C03CC01

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

Identification

ManufacturerPar Health USA, LLC

CountryUS (United States)

ATC codeC03CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4202315701
1 VIAL in 1 CARTON (42023-157-01) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

K41MYV7MPM

ETHACRYNATE SODIUM

RxCUI 4108

Orange Book

A205473

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "K41MYV7MPM",
    "rxcui": "4108",
    "inchikey": "CWCSCNSKBSCYCS-UHFFFAOYSA-M",
    "display_name": "ETHACRYNATE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e24e7440-a958-6fd0-6bfe-1bd29e638657": {
      "match": "brand_token",
      "title": "ETHACRYNATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LEADING PHARMA, LLC]",
      "spl_version": "3",
      "published_date": "2026-01-16"
    }
  },
  "productid": "42023-157_923d3573-ccd0-4c71-82e3-6167a23b9161",
  "productndc": "42023-157",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "205473",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jul 29, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHACRYNATE SODIUM",
  "proprietary_name": "ETHACRYNATE SODIUM",
  "active_ingred_unit": "mg/50mL",
  "application_number": "ANDA205473",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ethacrynate sodium",
  "start_marketing_date": "20150730",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code C03CC01.

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