amlodipine and olmesartan medoxomil (67877-499)

Drug Facts

Product Profile

Brand Name amlodipine and olmesartan medoxomil

Generic Name amlodipine and olmesartan medoxomil

Labeler ascend laboratories, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-499

Product ID 67877-499_32238052-6c4c-4b29-a59e-524c819c69f1

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209042

Listing Expiration 2026-12-31

Marketing Start 2017-08-14

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 67877499

Hyphenated Format 67877-499

Supplemental Identifiers

RxCUI

730861 730866 730869 730872

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 ANDA209042 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
20 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (67877-499-30)
90 TABLET in 1 BOTTLE (67877-499-90)

source: ndc

Packages (2)

67877-499-30 30 TABLET in 1 BOTTLE (67877-499-30) 67877-499-90 90 TABLET in 1 BOTTLE (67877-499-90)

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": "32238052-6c4c-4b29-a59e-524c819c69f1", "openfda": {"unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["c1204fbe-d086-43cf-bbaa-efec9cd0487c"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (67877-499-30)", "package_ndc": "67877-499-30", "marketing_start_date": "20170814"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (67877-499-90)", "package_ndc": "67877-499-90", "marketing_start_date": "20170814"}], "brand_name": "Amlodipine and olmesartan Medoxomil", "product_id": "67877-499_32238052-6c4c-4b29-a59e-524c819c69f1", "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": "67877-499", "generic_name": "Amlodipine and olmesartan Medoxomil", "labeler_name": "Ascend Laboratories, 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": "20 mg/1"}], "application_number": "ANDA209042", "marketing_category": "ANDA", "marketing_start_date": "20170814", "listing_expiration_date": "20261231"}