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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
- ndc110555048302100 TABLET in 1 BOTTLE (0555-0483-02)
- ndc1105550483051000 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"
}Related drugs
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Access this data programmatically
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