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United States · US · US:49884-117_cee18f3c-6f68-46d0-9e69-72c504c5a798

Amiloride Hydrochloride

Orange BookUNIISPLATC C03DB01

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

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeC03DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4988411701
    100 TABLET in 1 BOTTLE (49884-117-01)
  • ndc11
    4988411710
    1000 TABLET in 1 BOTTLE (49884-117-10)

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": "49884-117_cee18f3c-6f68-46d0-9e69-72c504c5a798",
  "productndc": "49884-117",
  "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

Other records sharing ATC code C03DB01.

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