candesartan cilexetil and hydrochlorothiazide (62559-661)

Drug Facts

Product Profile

Brand Name candesartan cilexetil and hydrochlorothiazide

Generic Name candesartan cilexetil and hydrochlorothiazide

Labeler ani pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

candesartan cilexetil 32 mg/1, hydrochlorothiazide 12.5 mg/1

Manufacturer

ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-661

Product ID 62559-661_f88f68dc-85bd-494d-b111-07701c619ea5

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA AUTHORIZED GENERIC

Application Number NDA021093

Listing Expiration 2026-12-31

Marketing Start 2018-09-26

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 62559661

Hyphenated Format 62559-661

Supplemental Identifiers

RxCUI

578325 578330 802749

UPC

0362559662901 0362559661904 0362559660907

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 NDA021093 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

32 mg/1
12.5 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE (62559-661-90)

source: ndc

Packages (1)

62559-661-90 90 TABLET in 1 BOTTLE (62559-661-90)

Ingredients (2)

candesartan cilexetil (32 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": "f88f68dc-85bd-494d-b111-07701c619ea5", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0362559662901", "0362559661904", "0362559660907"], "unii": ["0J48LPH2TH", "R85M2X0D68"], "rxcui": ["578325", "578330", "802749"], "spl_set_id": ["bd8d318d-167a-4b26-935d-265dde3193de"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62559-661-90)", "package_ndc": "62559-661-90", "marketing_start_date": "20180926"}], "brand_name": "Candesartan Cilexetil and Hydrochlorothiazide", "product_id": "62559-661_f88f68dc-85bd-494d-b111-07701c619ea5", "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": "62559-661", "generic_name": "Candesartan Cilexetil and Hydrochlorothiazide", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Candesartan Cilexetil and Hydrochlorothiazide", "active_ingredients": [{"name": "CANDESARTAN CILEXETIL", "strength": "32 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}], "application_number": "NDA021093", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180926", "listing_expiration_date": "20261231"}