amlodipine,valsartan and hydrochlorothiazide

Generic: amlodipine,valsartan and hydrochlorothiazide

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine,valsartan and hydrochlorothiazide
Generic Name amlodipine,valsartan and hydrochlorothiazide
Labeler macleods pharmaceuticals 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
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-283
Product ID 33342-283_1ea4f227-b97a-49f1-bbc3-1dede2c1866d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207299
Listing Expiration 2026-12-31
Marketing Start 2025-01-06

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 33342283
Hyphenated Format 33342-283

Supplemental Identifiers

RxCUI
848131 848135 848140 848145 848151
UPC
0333342283078 0333342287076 0333342284075
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 and hydrochlorothiazide (source: ndc)
Generic Name amlodipine,valsartan and hydrochlorothiazide (source: ndc)
Application Number ANDA207299 (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 (33342-283-07)
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-283-10)
  • 10 BLISTER PACK in 1 CARTON (33342-283-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

33342-283-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-283-07) 33342-283-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-283-10) 33342-283-12 10 BLISTER PACK in 1 CARTON (33342-283-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (12.5 mg/1) valsartan (160 mg/1)

Linked Drug Pages (1)

amlodipine,valsartan and hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ea4f227-b97a-49f1-bbc3-1dede2c1866d", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0333342283078", "0333342287076", "0333342284075"], "unii": ["0J48LPH2TH", "864V2Q084H", "80M03YXJ7I"], "rxcui": ["848131", "848135", "848140", "848145", "848151"], "spl_set_id": ["1ea4f227-b97a-49f1-bbc3-1dede2c1866d"], "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": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-283-07)", "package_ndc": "33342-283-07", "marketing_start_date": "20250106"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-283-10)", "package_ndc": "33342-283-10", "marketing_start_date": "20250106"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-283-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-283-12", "marketing_start_date": "20250106"}], "brand_name": "amlodipine,valsartan and hydrochlorothiazide", "product_id": "33342-283_1ea4f227-b97a-49f1-bbc3-1dede2c1866d", "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": "33342-283", "generic_name": "amlodipine,valsartan and hydrochlorothiazide", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "amlodipine,valsartan and 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": "ANDA207299", "marketing_category": "ANDA", "marketing_start_date": "20250106", "listing_expiration_date": "20261231"}