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United States · US · US:0555-0483_3c6d3a11-6d0b-4109-89cd-658827847fea

Amiloride Hydrochloride and Hydrochlorothiazide

Orange BookUNIISPLATC C03DB

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeC03DB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0555048302
    100 TABLET in 1 BOTTLE (0555-0483-02)
  • ndc11
    0555048305
    1000 TABLET in 1 BOTTLE (0555-0483-05)

Annotations

UNII (FDA Substance ID)
FZJ37245UC
AMILORIDE HYDROCHLORIDE
RxCUI 142424
Orange Book
A071111
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": "0555-0483_3c6d3a11-6d0b-4109-89cd-658827847fea",
  "productndc": "0555-0483",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "071111",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG ANHYDROUS;50MG",
        "product_no": "001",
        "approval_date": "May 10, 1988"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE",
  "proprietary_name": "Amiloride Hydrochloride and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA071111",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amiloride Hydrochloride and Hydrochlorothiazide",
  "start_marketing_date": "19891201",
  "active_numerator_strength": "5; 50"
}

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