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 43353-240
Product ID 43353-240_e5f8cae3-76be-4f78-9b8a-690bacf28a09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040702
Listing Expiration 2026-12-31
Marketing Start 2007-03-01

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 43353240
Hyphenated Format 43353-240

Supplemental Identifiers

RxCUI
197770
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 ANDA040702 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 45 TABLET in 1 BOTTLE, PLASTIC (43353-240-45)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43353-240-60)
source: ndc

Packages (2)

43353-240-45 45 TABLET in 1 BOTTLE, PLASTIC (43353-240-45) 43353-240-60 90 TABLET in 1 BOTTLE, PLASTIC (43353-240-60)

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": "e5f8cae3-76be-4f78-9b8a-690bacf28a09", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH"], "rxcui": ["197770"], "spl_set_id": ["2febae4f-836e-4935-bd06-3495f87b3b82"], "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": "45 TABLET in 1 BOTTLE, PLASTIC (43353-240-45)", "package_ndc": "43353-240-45", "marketing_start_date": "20161004"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43353-240-60)", "package_ndc": "43353-240-60", "marketing_start_date": "20160515"}], "brand_name": "HYDROCHLOROTHIAZIDE", "product_id": "43353-240_e5f8cae3-76be-4f78-9b8a-690bacf28a09", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "43353-240", "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": "ANDA040702", "marketing_category": "ANDA", "marketing_start_date": "20070301", "listing_expiration_date": "20261231"}