amlodipine and olmesartan medoxomil (68462-568)

Drug Facts

Product Profile

Brand Name amlodipine and olmesartan medoxomil

Generic Name amlodipine and olmesartan medoxomil

Labeler glenmark pharmaceuticals inc., usa

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-568

Product ID 68462-568_6de4a776-9973-4410-ae04-99544813d920

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207807

Listing Expiration 2026-12-31

Marketing Start 2017-07-05

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 68462568

Hyphenated Format 68462-568

Supplemental Identifiers

RxCUI

730861 730866 730869 730872

UPC

0368462568309 0368462567302 0368462569306 0368462566305

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 ANDA207807 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
40 mg/1

source: ndc

Packaging

10 BLISTER PACK in 1 CARTON (68462-568-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK
30 TABLET, FILM COATED in 1 BOTTLE (68462-568-30)
90 TABLET, FILM COATED in 1 BOTTLE (68462-568-90)

source: ndc

Packages (3)

68462-568-14 10 BLISTER PACK in 1 CARTON (68462-568-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK 68462-568-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-568-30) 68462-568-90 90 TABLET, FILM COATED in 1 BOTTLE (68462-568-90)

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": "6de4a776-9973-4410-ae04-99544813d920", "openfda": {"upc": ["0368462568309", "0368462567302", "0368462569306", "0368462566305"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["2edf43fb-0755-4ffb-bc38-75a4e2432588"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68462-568-14)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68462-568-14", "marketing_start_date": "20170705"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-568-30)", "package_ndc": "68462-568-30", "marketing_start_date": "20170705"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68462-568-90)", "package_ndc": "68462-568-90", "marketing_start_date": "20170705"}], "brand_name": "Amlodipine and Olmesartan Medoxomil", "product_id": "68462-568_6de4a776-9973-4410-ae04-99544813d920", "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": "68462-568", "generic_name": "Amlodipine and Olmesartan Medoxomil", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "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": "ANDA207807", "marketing_category": "ANDA", "marketing_start_date": "20170705", "listing_expiration_date": "20261231"}