amlodipine, valsartan, hydrochlorothiazide

Generic: amlodipine besylate valsartan hydrochlorothiazide

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine, valsartan, hydrochlorothiazide
Generic Name amlodipine besylate valsartan hydrochlorothiazide
Labeler strides pharma science limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, hydrochlorothiazide 12.5 mg/1, valsartan 160 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-197
Product ID 64380-197_6c98cab6-e7ba-42ba-adf9-71fa67c0a403
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201087
Listing Expiration 2026-12-31
Marketing Start 2022-06-27

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 64380197
Hyphenated Format 64380-197

Supplemental Identifiers

RxCUI
848131 848135 848140 848145 848151
UPC
0364380197010 0364380199014 0364380200017 0364380201014
UNII
0J48LPH2TH 864V2Q084H 80M03YXJ7I
NUI
N0000175359 N0000175419 M0471776 N0000000070 N0000175561

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 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
  • 12.5 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (64380-197-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (64380-197-02)
  • 500 TABLET, FILM COATED in 1 BOTTLE (64380-197-03)
source: ndc

Packages (3)

64380-197-01 30 TABLET, FILM COATED in 1 BOTTLE (64380-197-01) 64380-197-02 90 TABLET, FILM COATED in 1 BOTTLE (64380-197-02) 64380-197-03 500 TABLET, FILM COATED in 1 BOTTLE (64380-197-03)

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (12.5 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": "6c98cab6-e7ba-42ba-adf9-71fa67c0a403", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0364380197010", "0364380199014", "0364380200017", "0364380201014"], "unii": ["0J48LPH2TH", "864V2Q084H", "80M03YXJ7I"], "rxcui": ["848131", "848135", "848140", "848145", "848151"], "spl_set_id": ["9b76e441-e6a5-4036-8276-b7788ade5c44"], "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": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (64380-197-01)", "package_ndc": "64380-197-01", "marketing_start_date": "20220627"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (64380-197-02)", "package_ndc": "64380-197-02", "marketing_start_date": "20220627"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (64380-197-03)", "package_ndc": "64380-197-03", "marketing_start_date": "20220627"}], "brand_name": "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE", "product_id": "64380-197_6c98cab6-e7ba-42ba-adf9-71fa67c0a403", "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": "64380-197", "generic_name": "amlodipine besylate valsartan hydrochlorothiazide", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA201087", "marketing_category": "ANDA", "marketing_start_date": "20220627", "listing_expiration_date": "20261231"}