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United States · US · US:68180-159_c8158f85-c286-402d-9cca-85bcfe4e4085

Ethacrynic Acid

Orange BookUNIISPLATC C03CC01

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC03CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6818015901
    100 TABLET in 1 BOTTLE (68180-159-01)

Annotations

UNII (FDA Substance ID)
M5DP350VZV
ETHACRYNIC ACID
RxCUI 4109
Orange Book
A211719
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "M5DP350VZV",
    "rxcui": "4109",
    "inchikey": "AVOLMBLBETYQHX-UHFFFAOYSA-N",
    "display_name": "ETHACRYNIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b9bc3907-bfa7-4d9f-90d9-c2097230f7e4": {
      "match": "brand_token",
      "title": "ETHACRYNIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "6",
      "published_date": "2026-04-27"
    }
  },
  "productid": "68180-159_c8158f85-c286-402d-9cca-85bcfe4e4085",
  "productndc": "68180-159",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211719",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Sep 6, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHACRYNIC ACID",
  "proprietary_name": "Ethacrynic Acid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211719",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ethacrynic Acid",
  "start_marketing_date": "20200224",
  "active_numerator_strength": "25"
}

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