candesartan cilexetil and hydrochlorothiazide (0378-3001)

Drug Facts

Product Profile

Brand Name candesartan cilexetil and hydrochlorothiazide

Generic Name candesartan cilexetil and hydrochlorothiazide

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3001

Product ID 0378-3001_b308024b-d9c2-4b12-ac28-cb2e295ab1bf

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090704

Marketing Start 2012-12-04

Marketing End 2027-02-28

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 03783001

Hyphenated Format 0378-3001

Supplemental Identifiers

RxCUI

578325 578330 802749

UPC

0303783003771 0303783001777 0303783002774

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 ANDA090704 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

16 mg/1
12.5 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE, PLASTIC (0378-3001-77)

source: ndc

Packages (1)

0378-3001-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-3001-77)

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": "b308024b-d9c2-4b12-ac28-cb2e295ab1bf", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0303783003771", "0303783001777", "0303783002774"], "unii": ["0J48LPH2TH", "R85M2X0D68"], "rxcui": ["578325", "578330", "802749"], "spl_set_id": ["f3c4f7ed-e667-4528-a675-b032c2a4425d"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (0378-3001-77)", "package_ndc": "0378-3001-77", "marketing_end_date": "20270228", "marketing_start_date": "20121204"}], "brand_name": "Candesartan Cilexetil and Hydrochlorothiazide", "product_id": "0378-3001_b308024b-d9c2-4b12-ac28-cb2e295ab1bf", "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": "0378-3001", "generic_name": "candesartan cilexetil and hydrochlorothiazide", "labeler_name": "Mylan 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": "ANDA090704", "marketing_category": "ANDA", "marketing_end_date": "20270228", "marketing_start_date": "20121204"}