olmesartan medoxomil, amlodipine and hydrochlorothiazide (0093-5003)

Drug Facts

Product Profile

Brand Name olmesartan medoxomil, amlodipine and hydrochlorothiazide

Generic Name olmesartan medoxomil, amlodipine and hydrochlorothiazide

Labeler teva pharmaceuticals usa, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amlodipine besylate 10 mg/1, hydrochlorothiazide 12.5 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer

Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5003

Product ID 0093-5003_a035edd9-948f-4168-b74b-9961a2cb219a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202491

Listing Expiration 2026-12-31

Marketing Start 2016-11-14

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 00935003

Hyphenated Format 0093-5003

Supplemental Identifiers

RxCUI

999967 999986 999991 999996 1000001

UNII

0J48LPH2TH 864V2Q084H 6M97XTV3HD

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 olmesartan medoxomil, amlodipine and hydrochlorothiazide (source: ndc)

Generic Name olmesartan medoxomil, amlodipine and hydrochlorothiazide (source: ndc)

Application Number ANDA202491 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
12.5 mg/1
40 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (0093-5003-56)

source: ndc

Packages (1)

0093-5003-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-5003-56)

Ingredients (3)

amlodipine besylate (10 mg/1) hydrochlorothiazide (12.5 mg/1) olmesartan medoxomil (40 mg/1)

Linked Drug Pages (1)

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "a035edd9-948f-4168-b74b-9961a2cb219a", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "864V2Q084H", "6M97XTV3HD"], "rxcui": ["999967", "999986", "999991", "999996", "1000001"], "spl_set_id": ["5c128ef2-60a6-40f3-b37f-ee139fe27987"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0093-5003-56)", "package_ndc": "0093-5003-56", "marketing_start_date": "20161114"}], "brand_name": "Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide", "product_id": "0093-5003_a035edd9-948f-4168-b74b-9961a2cb219a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "0093-5003", "generic_name": "Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA202491", "marketing_category": "ANDA", "marketing_start_date": "20161114", "listing_expiration_date": "20261231"}