candesartan cilexetil and hydrochlorothiazide

Generic: candesartan cilexetil and hydrochlorothiazide

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

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 16 mg/1, hydrochlorothiazide 12.5 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-660
Product ID 62559-660_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 62559660
Hyphenated Format 62559-660

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
  • 16 mg/1
  • 12.5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62559-660-90)
source: ndc

Packages (1)

62559-660-90 90 TABLET in 1 BOTTLE (62559-660-90)

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": "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 (62559-660-90)", "package_ndc": "62559-660-90", "marketing_start_date": "20180926"}], "brand_name": "Candesartan Cilexetil and Hydrochlorothiazide", "product_id": "62559-660_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": "62559-660", "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": "16 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"}