hydrochlorothiazide

Generic: hydrochlorothiazide

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrochlorothiazide
Generic Name hydrochlorothiazide
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 50 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-717
Product ID 43353-717_80c4cb36-638f-4d42-aa92-c5428ba5c547
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083177
Listing Expiration 2026-12-31
Marketing Start 1980-01-07

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 43353717
Hyphenated Format 43353-717

Supplemental Identifiers

RxCUI
197770 310798
UNII
0J48LPH2TH
NUI
N0000175359 N0000175419 M0471776

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 ANDA083177 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 9000 TABLET in 1 BOTTLE (43353-717-09)
  • 30 TABLET in 1 BOTTLE (43353-717-30)
  • 45 TABLET in 1 BOTTLE (43353-717-45)
  • 60 TABLET in 1 BOTTLE (43353-717-53)
  • 90 TABLET in 1 BOTTLE (43353-717-60)
source: ndc

Packages (5)

43353-717-09 9000 TABLET in 1 BOTTLE (43353-717-09) 43353-717-30 30 TABLET in 1 BOTTLE (43353-717-30) 43353-717-45 45 TABLET in 1 BOTTLE (43353-717-45) 43353-717-53 60 TABLET in 1 BOTTLE (43353-717-53) 43353-717-60 90 TABLET in 1 BOTTLE (43353-717-60)

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": "80c4cb36-638f-4d42-aa92-c5428ba5c547", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH"], "rxcui": ["197770", "310798"], "spl_set_id": ["61487122-8a94-4ad5-a307-7893e0b7510c"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET in 1 BOTTLE (43353-717-09)", "package_ndc": "43353-717-09", "marketing_start_date": "20170507"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (43353-717-30)", "package_ndc": "43353-717-30", "marketing_start_date": "20110412"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (43353-717-45)", "package_ndc": "43353-717-45", "marketing_start_date": "20170814"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43353-717-53)", "package_ndc": "43353-717-53", "marketing_start_date": "20110412"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-717-60)", "package_ndc": "43353-717-60", "marketing_start_date": "20110412"}], "brand_name": "Hydrochlorothiazide", "product_id": "43353-717_80c4cb36-638f-4d42-aa92-c5428ba5c547", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "43353-717", "generic_name": "Hydrochlorothiazide", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "50 mg/1"}], "application_number": "ANDA083177", "marketing_category": "ANDA", "marketing_start_date": "19800107", "listing_expiration_date": "20261231"}