amlodipine and valsartan (0378-1721)

Drug Facts

Product Profile

Brand Name amlodipine and valsartan

Generic Name amlodipine and valsartan

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1721

Product ID 0378-1721_97bfe7c1-7e4b-45a1-b045-ff48275f1488

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090483

Listing Expiration 2026-12-31

Marketing Start 2015-03-30

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 03781721

Hyphenated Format 0378-1721

Supplemental Identifiers

RxCUI

722126 722131 722134 722137

UPC

0303781722933 0303781723930 0303781721936 0303781724937

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 ANDA090483 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
160 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1721-93)

source: ndc

Packages (1)

0378-1721-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1721-93)

Ingredients (2)

amlodipine besylate (5 mg/1) valsartan (160 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": "97bfe7c1-7e4b-45a1-b045-ff48275f1488", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0303781722933", "0303781723930", "0303781721936", "0303781724937"], "unii": ["864V2Q084H", "80M03YXJ7I"], "rxcui": ["722126", "722131", "722134", "722137"], "spl_set_id": ["aa7e7d95-520a-461c-b1b3-e588aeb6a613"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1721-93)", "package_ndc": "0378-1721-93", "marketing_start_date": "20150330"}], "brand_name": "AMLODIPINE AND VALSARTAN", "product_id": "0378-1721_97bfe7c1-7e4b-45a1-b045-ff48275f1488", "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]"], "product_ndc": "0378-1721", "generic_name": "AMLODIPINE AND VALSARTAN", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE AND VALSARTAN", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA090483", "marketing_category": "ANDA", "marketing_start_date": "20150330", "listing_expiration_date": "20261231"}