amlodipine and valsartan (43386-081)

Drug Facts

Product Profile

Brand Name amlodipine and valsartan

Generic Name amlodipine and valsartan

Labeler lupin pharmaceuticals,inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-081

Product ID 43386-081_8d66a9ba-050e-4993-939b-f2c858760a0c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202829

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 43386081

Hyphenated Format 43386-081

Supplemental Identifiers

RxCUI

722126 722131 722134 722137

UPC

0343386083039 0343386082094 0343386080090 0343386081035

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 ANDA202829 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
320 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (43386-081-03)
90 TABLET in 1 BOTTLE (43386-081-09)

source: ndc

Packages (2)

43386-081-03 30 TABLET in 1 BOTTLE (43386-081-03) 43386-081-09 90 TABLET in 1 BOTTLE (43386-081-09)

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": "8d66a9ba-050e-4993-939b-f2c858760a0c", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0343386083039", "0343386082094", "0343386080090", "0343386081035"], "unii": ["864V2Q084H", "80M03YXJ7I"], "rxcui": ["722126", "722131", "722134", "722137"], "spl_set_id": ["e05dd72c-7475-422e-bf8e-73148929450e"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43386-081-03)", "package_ndc": "43386-081-03", "marketing_start_date": "20150330"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43386-081-09)", "package_ndc": "43386-081-09", "marketing_start_date": "20150330"}], "brand_name": "AMLODIPINE AND VALSARTAN", "product_id": "43386-081_8d66a9ba-050e-4993-939b-f2c858760a0c", "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": "43386-081", "generic_name": "amlodipine and valsartan", "labeler_name": "Lupin 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": "320 mg/1"}], "application_number": "ANDA202829", "marketing_category": "ANDA", "marketing_start_date": "20150330", "listing_expiration_date": "20261231"}