candesartan cilexetil and hydrochlorothiazide (43547-459)

Drug Facts

Product Profile

Brand Name candesartan cilexetil and hydrochlorothiazide

Generic Name candesartan cilexetil and hydrochlorothiazide

Labeler solco healthcare llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Solco Healthcare LLC

Identifiers & Regulatory

Product NDC 43547-459

Product ID 43547-459_745438ab-c3fe-4da9-9548-730970399e0d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207455

Listing Expiration 2026-12-31

Marketing Start 2017-11-20

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 43547459

Hyphenated Format 43547-459

Supplemental Identifiers

RxCUI

578325 578330 802749

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 ANDA207455 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

16 mg/1
12.5 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE (43547-459-09)
500 TABLET in 1 BOTTLE (43547-459-50)

source: ndc

Packages (2)

43547-459-09 90 TABLET in 1 BOTTLE (43547-459-09) 43547-459-50 500 TABLET in 1 BOTTLE (43547-459-50)

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": "745438ab-c3fe-4da9-9548-730970399e0d", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "R85M2X0D68"], "rxcui": ["578325", "578330", "802749"], "spl_set_id": ["543b9806-ccfa-4144-a2a2-d0e35eaceeee"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Solco Healthcare LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-459-09)", "package_ndc": "43547-459-09", "marketing_start_date": "20171120"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-459-50)", "package_ndc": "43547-459-50", "marketing_start_date": "20171120"}], "brand_name": "candesartan cilexetil and hydrochlorothiazide", "product_id": "43547-459_745438ab-c3fe-4da9-9548-730970399e0d", "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": "43547-459", "generic_name": "candesartan cilexetil and hydrochlorothiazide", "labeler_name": "Solco Healthcare LLC", "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": "ANDA207455", "marketing_category": "ANDA", "marketing_start_date": "20171120", "listing_expiration_date": "20261231"}