amlodipine and olmesartan medoxomil (69238-2676)

Drug Facts

Product Profile

Brand Name amlodipine and olmesartan medoxomil

Generic Name amlodipine and olmesartan medoxomil

Labeler amneal pharmaceuticals ny llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amlodipine besylate 5 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer

Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2676

Product ID 69238-2676_31d0d1f2-a0c7-4cd3-80d2-d9f231687adc

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209010

Listing Expiration 2026-12-31

Marketing Start 2018-12-03

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 692382676

Hyphenated Format 69238-2676

Supplemental Identifiers

RxCUI

730861 730866 730869 730872

UPC

0369238267617 0369238267518 0369238267310 0369238267419

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 ANDA209010 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
40 mg/1

source: ndc

Packaging

1000 TABLET, FILM COATED in 1 BOTTLE (69238-2676-1)

source: ndc

Packages (1)

69238-2676-1 1000 TABLET, FILM COATED in 1 BOTTLE (69238-2676-1)

Ingredients (2)

amlodipine besylate (5 mg/1) olmesartan medoxomil (40 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": "31d0d1f2-a0c7-4cd3-80d2-d9f231687adc", "openfda": {"upc": ["0369238267617", "0369238267518", "0369238267310", "0369238267419"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["02f9b562-6f7f-4783-bb0d-67c318073e1c"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69238-2676-1)", "package_ndc": "69238-2676-1", "marketing_start_date": "20181203"}], "brand_name": "Amlodipine and Olmesartan Medoxomil", "product_id": "69238-2676_31d0d1f2-a0c7-4cd3-80d2-d9f231687adc", "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": "69238-2676", "generic_name": "Amlodipine and Olmesartan Medoxomil", "labeler_name": "Amneal Pharmaceuticals NY LLC", "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": "40 mg/1"}], "application_number": "ANDA209010", "marketing_category": "ANDA", "marketing_start_date": "20181203", "listing_expiration_date": "20261231"}