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United States · US · US:63629-2114_84adc61b-3ed3-452d-a1b8-d062869b263d

Amiloride Hydrochloride

Orange BookUNIISPLATC C03DB01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC03DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362921141
    1000 TABLET in 1 BOTTLE (63629-2114-1)

Annotations

UNII (FDA Substance ID)
7M458Q65S3
AMILORIDE HYDROCHLORIDE ANHYDROUS
RxCUI 1298837
Orange Book
A070346
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7M458Q65S3",
    "rxcui": "1298837",
    "inchikey": "ACHKKGDWZVCSNH-UHFFFAOYSA-N",
    "display_name": "AMILORIDE HYDROCHLORIDE ANHYDROUS",
    "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": "63629-2114_84adc61b-3ed3-452d-a1b8-d062869b263d",
  "productndc": "63629-2114",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "070346",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 22, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMILORIDE HYDROCHLORIDE ANHYDROUS",
  "proprietary_name": "Amiloride Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA070346",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amiloride Hydrochloride",
  "start_marketing_date": "19860122",
  "active_numerator_strength": "5"
}

Related drugs

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