amlodipine and olmesartan medoxomil (65862-854)

Drug Facts

Product Profile

Brand Name amlodipine and olmesartan medoxomil

Generic Name amlodipine and olmesartan medoxomil

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amlodipine besylate 5 mg/1, olmesartan medoxomil 20 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-854

Product ID 65862-854_4879a01c-0ba7-4d27-9847-f22e8546fa8f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206906

Listing Expiration 2026-12-31

Marketing Start 2017-05-15

Pharmacologic Class

Classes

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862854

Hyphenated Format 65862-854

Supplemental Identifiers

RxCUI

730861 730866 730869 730872

UPC

0365862855305 0365862856302 0365862854308 0365862857309

UNII

864V2Q084H 6M97XTV3HD

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 olmesartan medoxomil (source: ndc)

Generic Name amlodipine and olmesartan medoxomil (source: ndc)

Application Number ANDA206906 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
20 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (65862-854-30)

source: ndc

Packages (1)

65862-854-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-854-30)

Ingredients (2)

amlodipine besylate (5 mg/1) olmesartan medoxomil (20 mg/1)

Linked Drug Pages (1)

Amlodipine and Olmesartan Medoxomil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4879a01c-0ba7-4d27-9847-f22e8546fa8f", "openfda": {"upc": ["0365862855305", "0365862856302", "0365862854308", "0365862857309"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["b13a8b46-104e-4b75-8f4a-928d2204eff5"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-854-30)", "package_ndc": "65862-854-30", "marketing_start_date": "20170515"}], "brand_name": "Amlodipine and Olmesartan Medoxomil", "product_id": "65862-854_4879a01c-0ba7-4d27-9847-f22e8546fa8f", "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": "65862-854", "generic_name": "Amlodipine and Olmesartan Medoxomil", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and Olmesartan Medoxomil", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "20 mg/1"}], "application_number": "ANDA206906", "marketing_category": "ANDA", "marketing_start_date": "20170515", "listing_expiration_date": "20261231"}