hydrochlorothiazide

Generic: hydrochlorothiazide

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrochlorothiazide
Generic Name hydrochlorothiazide
Labeler leading pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-131
Product ID 69315-131_001b600e-a6f4-4f39-bdd3-cf29fb96fa83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040702
Listing Expiration 2026-12-31
Marketing Start 2016-04-01

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 69315131
Hyphenated Format 69315-131

Supplemental Identifiers

RxCUI
197770 310798 429503
UPC
0369315131107 0369315131503 0369315130100 0369315155103
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 ANDA040702 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (69315-131-01)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (69315-131-10)
  • 5000 TABLET in 1 BOTTLE, PLASTIC (69315-131-50)
source: ndc

Packages (3)

69315-131-01 100 TABLET in 1 BOTTLE, PLASTIC (69315-131-01) 69315-131-10 1000 TABLET in 1 BOTTLE, PLASTIC (69315-131-10) 69315-131-50 5000 TABLET in 1 BOTTLE, PLASTIC (69315-131-50)

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": "001b600e-a6f4-4f39-bdd3-cf29fb96fa83", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0369315131107", "0369315131503", "0369315130100", "0369315155103"], "unii": ["0J48LPH2TH"], "rxcui": ["197770", "310798", "429503"], "spl_set_id": ["8c868894-667e-4a51-906a-838d63e420ba"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (69315-131-01)", "package_ndc": "69315-131-01", "marketing_start_date": "20160401"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (69315-131-10)", "package_ndc": "69315-131-10", "marketing_start_date": "20160401"}, {"sample": false, "description": "5000 TABLET in 1 BOTTLE, PLASTIC (69315-131-50)", "package_ndc": "69315-131-50", "marketing_start_date": "20160401"}], "brand_name": "HYDROCHLOROTHIAZIDE", "product_id": "69315-131_001b600e-a6f4-4f39-bdd3-cf29fb96fa83", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "69315-131", "generic_name": "HYDROCHLOROTHIAZIDE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}], "application_number": "ANDA040702", "marketing_category": "ANDA", "marketing_start_date": "20160401", "listing_expiration_date": "20261231"}