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 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-719
Product ID 43353-719_80c4cb36-638f-4d42-aa92-c5428ba5c547
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083177
Listing Expiration 2026-12-31
Marketing Start 1973-01-12

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 43353719
Hyphenated Format 43353-719

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
  • 25 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (43353-719-15)
  • 30 TABLET in 1 BOTTLE (43353-719-30)
  • 45 TABLET in 1 BOTTLE (43353-719-45)
  • 60 TABLET in 1 BOTTLE (43353-719-53)
  • 90 TABLET in 1 BOTTLE (43353-719-60)
  • 100 TABLET in 1 BOTTLE (43353-719-65)
  • 135 TABLET in 1 BOTTLE (43353-719-73)
  • 180 TABLET in 1 BOTTLE (43353-719-80)
source: ndc

Packages (8)

43353-719-15 15 TABLET in 1 BOTTLE (43353-719-15) 43353-719-30 30 TABLET in 1 BOTTLE (43353-719-30) 43353-719-45 45 TABLET in 1 BOTTLE (43353-719-45) 43353-719-53 60 TABLET in 1 BOTTLE (43353-719-53) 43353-719-60 90 TABLET in 1 BOTTLE (43353-719-60) 43353-719-65 100 TABLET in 1 BOTTLE (43353-719-65) 43353-719-73 135 TABLET in 1 BOTTLE (43353-719-73) 43353-719-80 180 TABLET in 1 BOTTLE (43353-719-80)

Ingredients (1)

hydrochlorothiazide (25 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": "15 TABLET in 1 BOTTLE (43353-719-15)", "package_ndc": "43353-719-15", "marketing_start_date": "20110413"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (43353-719-30)", "package_ndc": "43353-719-30", "marketing_start_date": "20110413"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (43353-719-45)", "package_ndc": "43353-719-45", "marketing_start_date": "20110413"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43353-719-53)", "package_ndc": "43353-719-53", "marketing_start_date": "20110413"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-719-60)", "package_ndc": "43353-719-60", "marketing_start_date": "20110413"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (43353-719-65)", "package_ndc": "43353-719-65", "marketing_start_date": "20110413"}, {"sample": false, "description": "135 TABLET in 1 BOTTLE (43353-719-73)", "package_ndc": "43353-719-73", "marketing_start_date": "20110413"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (43353-719-80)", "package_ndc": "43353-719-80", "marketing_start_date": "20110413"}], "brand_name": "Hydrochlorothiazide", "product_id": "43353-719_80c4cb36-638f-4d42-aa92-c5428ba5c547", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "43353-719", "generic_name": "Hydrochlorothiazide", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}], "application_number": "ANDA083177", "marketing_category": "ANDA", "marketing_start_date": "19730112", "listing_expiration_date": "20261231"}