candesartan cilexetil and hydrochlorothiazide (33342-131)

Drug Facts

Product Profile

Brand Name candesartan cilexetil and hydrochlorothiazide

Generic Name candesartan cilexetil and hydrochlorothiazide

Labeler macleods pharmaceuticals limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

candesartan cilexetil 16 mg/1, hydrochlorothiazide 12.5 mg/1

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-131

Product ID 33342-131_66ca941e-6590-41a6-8d8f-caa2013089d0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204100

Listing Expiration 2026-12-31

Marketing Start 2015-03-07

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 33342131

Hyphenated Format 33342-131

Supplemental Identifiers

RxCUI

578325 578330 802749

UPC

0333342133106 0333342131515 0333342132109 0333342131102

UNII

0J48LPH2TH R85M2X0D68

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 candesartan cilexetil and hydrochlorothiazide (source: ndc)

Generic Name candesartan cilexetil and hydrochlorothiazide (source: ndc)

Application Number ANDA204100 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

16 mg/1
12.5 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE (33342-131-10)
10 BLISTER PACK in 1 CARTON (33342-131-12) / 10 TABLET in 1 BLISTER PACK
500 TABLET in 1 BOTTLE (33342-131-15)
300 TABLET in 1 BOTTLE (33342-131-51)

source: ndc

Packages (4)

33342-131-10 90 TABLET in 1 BOTTLE (33342-131-10) 33342-131-12 10 BLISTER PACK in 1 CARTON (33342-131-12) / 10 TABLET in 1 BLISTER PACK 33342-131-15 500 TABLET in 1 BOTTLE (33342-131-15) 33342-131-51 300 TABLET in 1 BOTTLE (33342-131-51)

Ingredients (2)

candesartan cilexetil (16 mg/1) hydrochlorothiazide (12.5 mg/1)

Linked Drug Pages (1)

Candesartan Cilexetil and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "66ca941e-6590-41a6-8d8f-caa2013089d0", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0333342133106", "0333342131515", "0333342132109", "0333342131102"], "unii": ["0J48LPH2TH", "R85M2X0D68"], "rxcui": ["578325", "578330", "802749"], "spl_set_id": ["76630807-9717-44be-946d-756038cf677e"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-131-10)", "package_ndc": "33342-131-10", "marketing_start_date": "20150307"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-131-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-131-12", "marketing_start_date": "20150307"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (33342-131-15)", "package_ndc": "33342-131-15", "marketing_start_date": "20150307"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (33342-131-51)", "package_ndc": "33342-131-51", "marketing_start_date": "20150307"}], "brand_name": "Candesartan Cilexetil and Hydrochlorothiazide", "product_id": "33342-131_66ca941e-6590-41a6-8d8f-caa2013089d0", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "33342-131", "generic_name": "Candesartan Cilexetil and Hydrochlorothiazide", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Candesartan Cilexetil and Hydrochlorothiazide", "active_ingredients": [{"name": "CANDESARTAN CILEXETIL", "strength": "16 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA204100", "marketing_category": "ANDA", "marketing_start_date": "20150307", "listing_expiration_date": "20261231"}