amlodipine and valsartan (33342-281)

Drug Facts

Product Profile

Brand Name amlodipine and valsartan

Generic Name amlodipine and valsartan

Labeler macleods pharmaceuticals limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

amlodipine besylate 5 mg/1, valsartan 320 mg/1

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-281

Product ID 33342-281_d520c66f-440c-4f7e-b057-0d548c3142e7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207292

Listing Expiration 2026-12-31

Marketing Start 2024-10-16

Pharmacologic Class

Established (EPC)

angiotensin 2 receptor blocker [epc]

Mechanism of Action

angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342281

Hyphenated Format 33342-281

Supplemental Identifiers

RxCUI

722126 722131 722134 722137

UPC

0333342280107 0333342282101 0333342279071 0333342281104 0333342281074 0333342282071 0333342279101

UNII

864V2Q084H 80M03YXJ7I

NUI

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 and valsartan (source: ndc)

Generic Name amlodipine and valsartan (source: ndc)

Application Number ANDA207292 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
320 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (33342-281-07)
90 TABLET in 1 BOTTLE (33342-281-10)
10 BLISTER PACK in 1 CARTON (33342-281-12) / 10 TABLET in 1 BLISTER PACK

source: ndc

Packages (3)

33342-281-07 30 TABLET in 1 BOTTLE (33342-281-07) 33342-281-10 90 TABLET in 1 BOTTLE (33342-281-10) 33342-281-12 10 BLISTER PACK in 1 CARTON (33342-281-12) / 10 TABLET in 1 BLISTER PACK

Ingredients (2)

amlodipine besylate (5 mg/1) valsartan (320 mg/1)

Linked Drug Pages (1)

amlodipine and valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "d520c66f-440c-4f7e-b057-0d548c3142e7", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0333342280107", "0333342282101", "0333342279071", "0333342281104", "0333342281074", "0333342282071", "0333342279101"], "unii": ["864V2Q084H", "80M03YXJ7I"], "rxcui": ["722126", "722131", "722134", "722137"], "spl_set_id": ["5dfadaf0-c333-4b79-9a97-e42f77505c40"], "pharm_class_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 in 1 BOTTLE (33342-281-07)", "package_ndc": "33342-281-07", "marketing_start_date": "20241016"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-281-10)", "package_ndc": "33342-281-10", "marketing_start_date": "20241016"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-281-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-281-12", "marketing_start_date": "20241016"}], "brand_name": "amlodipine and valsartan", "product_id": "33342-281_d520c66f-440c-4f7e-b057-0d548c3142e7", "dosage_form": "TABLET", "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]"], "product_ndc": "33342-281", "generic_name": "amlodipine and valsartan", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "amlodipine and valsartan", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "VALSARTAN", "strength": "320 mg/1"}], "application_number": "ANDA207292", "marketing_category": "ANDA", "marketing_start_date": "20241016", "listing_expiration_date": "20261231"}