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United States · US · US:0574-0292_416c3aaf-7390-40cf-995a-31258156b4f2

amiloride hydrochloride

Orange BookUNIISPLATC C03DB01

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

Identification

ManufacturerPadagis US LLC
CountryUS (United States)
ATC codeC03DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0574029201
    100 TABLET in 1 BOTTLE (0574-0292-01)

Annotations

UNII (FDA Substance ID)
FZJ37245UC
AMILORIDE HYDROCHLORIDE
RxCUI 142424
Orange Book
N018200
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FZJ37245UC",
    "rxcui": "142424",
    "inchikey": "LTKVFMLMEYCWMK-UHFFFAOYSA-N",
    "display_name": "AMILORIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e0cc2d44-436a-47e8-a890-589882fff4c4": {
      "match": "brand_token",
      "title": "AMILORIDE HYDROCHLORIDE TABLET [ENDO USA, INC.]",
      "spl_version": "11",
      "published_date": "2025-01-09"
    }
  },
  "productid": "0574-0292_416c3aaf-7390-40cf-995a-31258156b4f2",
  "productndc": "0574-0292",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "018200",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMILORIDE HYDROCHLORIDE",
  "proprietary_name": "amiloride hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018200",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "amiloride hydrochloride",
  "start_marketing_date": "20090406",
  "active_numerator_strength": "5"
}

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