amiloride hydrochloride and hydrochlorothiazide (0555-0483)

Drug Facts

Product Profile

Brand Name amiloride hydrochloride and hydrochlorothiazide

Generic Name amiloride hydrochloride and hydrochlorothiazide

Labeler teva pharmaceuticals usa, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

amiloride hydrochloride 5 mg/1, hydrochlorothiazide 50 mg/1

Manufacturer

Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-0483

Product ID 0555-0483_3c6d3a11-6d0b-4109-89cd-658827847fea

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA071111

Listing Expiration 2026-12-31

Marketing Start 1989-12-01

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05550483

Hyphenated Format 0555-0483

Supplemental Identifiers

RxCUI

977883

UNII

FZJ37245UC 0J48LPH2TH

NUI

N0000175359 N0000175419 M0471776

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amiloride hydrochloride and hydrochlorothiazide (source: ndc)

Generic Name amiloride hydrochloride and hydrochlorothiazide (source: ndc)

Application Number ANDA071111 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
50 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (0555-0483-02)
1000 TABLET in 1 BOTTLE (0555-0483-05)

source: ndc

Packages (2)

0555-0483-02 100 TABLET in 1 BOTTLE (0555-0483-02) 0555-0483-05 1000 TABLET in 1 BOTTLE (0555-0483-05)

Ingredients (2)

amiloride hydrochloride (5 mg/1) hydrochlorothiazide (50 mg/1)

Linked Drug Pages (1)

Amiloride Hydrochloride and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3c6d3a11-6d0b-4109-89cd-658827847fea", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["FZJ37245UC", "0J48LPH2TH"], "rxcui": ["977883"], "spl_set_id": ["8b2c581a-f955-4a8e-bf85-e768e903fd10"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0555-0483-02)", "package_ndc": "0555-0483-02", "marketing_start_date": "19891201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0555-0483-05)", "package_ndc": "0555-0483-05", "marketing_start_date": "19891201"}], "brand_name": "Amiloride Hydrochloride and Hydrochlorothiazide", "product_id": "0555-0483_3c6d3a11-6d0b-4109-89cd-658827847fea", "dosage_form": "TABLET", "pharm_class": ["Decreased Renal K+ Excretion [PE]", "Increased Diuresis [PE]", "Increased Diuresis [PE]", "Potassium-sparing Diuretic [EPC]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "0555-0483", "generic_name": "Amiloride Hydrochloride and Hydrochlorothiazide", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiloride Hydrochloride and Hydrochlorothiazide", "active_ingredients": [{"name": "AMILORIDE HYDROCHLORIDE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "50 mg/1"}], "application_number": "ANDA071111", "marketing_category": "ANDA", "marketing_start_date": "19891201", "listing_expiration_date": "20261231"}