amlodipine and valsartan (0378-1722)

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 10 mg/1, valsartan 160 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1722

Product ID 0378-1722_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 03781722

Hyphenated Format 0378-1722

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

10 mg/1
160 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1722-93)

source: ndc

Packages (1)

0378-1722-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1722-93)

Ingredients (2)

amlodipine besylate (10 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 (0378-1722-93)", "package_ndc": "0378-1722-93", "marketing_start_date": "20150330"}], "brand_name": "AMLODIPINE AND VALSARTAN", "product_id": "0378-1722_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": "0378-1722", "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": "10 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA090483", "marketing_category": "ANDA", "marketing_start_date": "20150330", "listing_expiration_date": "20261231"}