amlodipine, valsartan, hydrochlorothiazide (51407-669)

Drug Facts

Product Profile

Brand Name amlodipine, valsartan, hydrochlorothiazide

Generic Name amlodipine besylate valsartan hydrochlorothiazide

Labeler golden state medical supply, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amlodipine besylate 5 mg/1, hydrochlorothiazide 25 mg/1, valsartan 160 mg/1

Manufacturer

Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-669

Product ID 51407-669_369be7a6-2236-ab19-e063-6394a90a880f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201087

Listing Expiration 2026-12-31

Marketing Start 2015-06-01

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc] angiotensin 2 receptor blocker [epc]

Mechanism of Action

angiotensin 2 receptor antagonists [moa]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51407669

Hyphenated Format 51407-669

Supplemental Identifiers

RxCUI

848131 848135 848140 848145 848151

UNII

0J48LPH2TH 864V2Q084H 80M03YXJ7I

NUI

N0000175359 N0000175419 M0471776 N0000000070 N0000175561

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 amlodipine, valsartan, hydrochlorothiazide (source: ndc)

Generic Name amlodipine besylate valsartan hydrochlorothiazide (source: ndc)

Application Number ANDA201087 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
25 mg/1
160 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (51407-669-30)

source: ndc

Packages (1)

51407-669-30 30 TABLET, FILM COATED in 1 BOTTLE (51407-669-30)

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (25 mg/1) valsartan (160 mg/1)

Linked Drug Pages (1)

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "369be7a6-2236-ab19-e063-6394a90a880f", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "864V2Q084H", "80M03YXJ7I"], "rxcui": ["848131", "848135", "848140", "848145", "848151"], "spl_set_id": ["e9ecbadb-c548-6fe5-e053-2a95a90a7577"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (51407-669-30)", "package_ndc": "51407-669-30", "marketing_start_date": "20220801"}], "brand_name": "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE", "product_id": "51407-669_369be7a6-2236-ab19-e063-6394a90a880f", "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": "51407-669", "generic_name": "amlodipine besylate valsartan hydrochlorothiazide", "labeler_name": "Golden State Medical Supply, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA201087", "marketing_category": "ANDA", "marketing_start_date": "20150601", "listing_expiration_date": "20261231"}