candesartan cilexetil and hydrochlorothiazide

Generic: candesartan cilexetil and hydrochlorothiazide

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name candesartan cilexetil and hydrochlorothiazide
Generic Name candesartan cilexetil and hydrochlorothiazide
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1326
Product ID 70771-1326_2b38d778-d732-4a7b-bb34-b426a14e10bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203466
Listing Expiration 2026-12-31
Marketing Start 2018-04-14

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 707711326
Hyphenated Format 70771-1326

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 ANDA203466 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 32 mg/1
  • 12.5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1326-0)
  • 100 TABLET in 1 BOTTLE (70771-1326-1)
  • 30 TABLET in 1 BOTTLE (70771-1326-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1326-4) / 10 TABLET in 1 BLISTER PACK (70771-1326-2)
  • 90 TABLET in 1 BOTTLE (70771-1326-9)
source: ndc

Packages (5)

70771-1326-0 1000 TABLET in 1 BOTTLE (70771-1326-0) 70771-1326-1 100 TABLET in 1 BOTTLE (70771-1326-1) 70771-1326-3 30 TABLET in 1 BOTTLE (70771-1326-3) 70771-1326-4 10 BLISTER PACK in 1 CARTON (70771-1326-4) / 10 TABLET in 1 BLISTER PACK (70771-1326-2) 70771-1326-9 90 TABLET in 1 BOTTLE (70771-1326-9)

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": "2b38d778-d732-4a7b-bb34-b426a14e10bc", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "R85M2X0D68"], "rxcui": ["578325", "578330", "802749"], "spl_set_id": ["cb328bc1-5738-4620-b2b3-442e98388a86"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1326-0)", "package_ndc": "70771-1326-0", "marketing_start_date": "20180414"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1326-1)", "package_ndc": "70771-1326-1", "marketing_start_date": "20180414"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70771-1326-3)", "package_ndc": "70771-1326-3", "marketing_start_date": "20180414"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1326-4)  / 10 TABLET in 1 BLISTER PACK (70771-1326-2)", "package_ndc": "70771-1326-4", "marketing_start_date": "20180414"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70771-1326-9)", "package_ndc": "70771-1326-9", "marketing_start_date": "20180414"}], "brand_name": "candesartan cilexetil and hydrochlorothiazide", "product_id": "70771-1326_2b38d778-d732-4a7b-bb34-b426a14e10bc", "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": "70771-1326", "generic_name": "candesartan cilexetil and hydrochlorothiazide", "labeler_name": "Zydus Lifesciences Limited", "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": "ANDA203466", "marketing_category": "ANDA", "marketing_start_date": "20180414", "listing_expiration_date": "20261231"}