hydrochlorothiazide

Generic: hydrochlorothiazide

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrochlorothiazide
Generic Name hydrochlorothiazide
Labeler solco healthcare u.s., llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 50 mg/1

Manufacturer
Solco Healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-398
Product ID 43547-398_d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040412
Listing Expiration 2026-12-31
Marketing Start 2002-03-29

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 43547398
Hyphenated Format 43547-398

Supplemental Identifiers

RxCUI
197770 310798
UPC
0343547397036
UNII
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 hydrochlorothiazide (source: ndc)
Generic Name hydrochlorothiazide (source: ndc)
Application Number ANDA040412 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE, PLASTIC (43547-398-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43547-398-03)
  • 50 TABLET in 1 BOTTLE, PLASTIC (43547-398-05)
  • 100 TABLET in 1 BOTTLE, PLASTIC (43547-398-10)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (43547-398-11)
  • 500 TABLET in 1 BOTTLE, PLASTIC (43547-398-50)
source: ndc

Packages (6)

43547-398-01 10 TABLET in 1 BOTTLE, PLASTIC (43547-398-01) 43547-398-03 30 TABLET in 1 BOTTLE, PLASTIC (43547-398-03) 43547-398-05 50 TABLET in 1 BOTTLE, PLASTIC (43547-398-05) 43547-398-10 100 TABLET in 1 BOTTLE, PLASTIC (43547-398-10) 43547-398-11 1000 TABLET in 1 BOTTLE, PLASTIC (43547-398-11) 43547-398-50 500 TABLET in 1 BOTTLE, PLASTIC (43547-398-50)

Ingredients (1)

hydrochlorothiazide (50 mg/1)

Linked Drug Pages (1)

Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0343547397036"], "unii": ["0J48LPH2TH"], "rxcui": ["197770", "310798"], "spl_set_id": ["60c97ab9-b25e-4ea5-a159-792292178c65"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Solco Healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (43547-398-01)", "package_ndc": "43547-398-01", "marketing_start_date": "20020329"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43547-398-03)", "package_ndc": "43547-398-03", "marketing_start_date": "20020329"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE, PLASTIC (43547-398-05)", "package_ndc": "43547-398-05", "marketing_start_date": "20020329"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (43547-398-10)", "package_ndc": "43547-398-10", "marketing_start_date": "20020329"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (43547-398-11)", "package_ndc": "43547-398-11", "marketing_start_date": "20020329"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (43547-398-50)", "package_ndc": "43547-398-50", "marketing_start_date": "20020329"}], "brand_name": "Hydrochlorothiazide", "product_id": "43547-398_d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "43547-398", "generic_name": "Hydrochlorothiazide", "labeler_name": "Solco Healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "50 mg/1"}], "application_number": "ANDA040412", "marketing_category": "ANDA", "marketing_start_date": "20020329", "listing_expiration_date": "20261231"}