🇺🇸
United States · US · US:42794-005_f1f15fe7-63a8-4708-e053-2a95a90a7dea
Amiloride Hydrochloride
Orange BookUNIISPLATC C03DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSigmapharm Laboratories, LLC
CountryUS (United States)
ATC codeC03DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114279400502100 TABLET in 1 BOTTLE (42794-005-02)
Annotations
UNII (FDA Substance ID)
7M458Q65S3
AMILORIDE HYDROCHLORIDE ANHYDROUS
RxCUI 1298837
Orange Book
A079133
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": "42794-005_f1f15fe7-63a8-4708-e053-2a95a90a7dea",
"productndc": "42794-005",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "079133",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jan 30, 2009"
}
],
"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": "ANDA079133",
"marketing_category": "ANDA",
"nonproprietary_name": "Amiloride Hydrochloride",
"start_marketing_date": "20210614",
"active_numerator_strength": "5"
}Related drugs
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