amlodipine and olmesartan medoxomil (33342-191)

Drug Facts

Product Profile

Brand Name amlodipine and olmesartan medoxomil

Generic Name amlodipine and olmesartan medoxomil

Labeler macleods pharmaceuticals limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-191

Product ID 33342-191_bd687a21-be18-439a-8e65-103a15b4a8f8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206884

Listing Expiration 2027-12-31

Marketing Start 2016-10-27

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 33342191

Hyphenated Format 33342-191

Supplemental Identifiers

RxCUI

730861 730866 730869 730872

UPC

0333342192073 0333342191076 0333342192103 0333342190079 0333342193100 0333342191106 0333342193070 0333342190109

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 ANDA206884 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
40 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (33342-191-07)
90 TABLET, FILM COATED in 1 BOTTLE (33342-191-10)
10 BLISTER PACK in 1 CARTON (33342-191-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
1000 TABLET, FILM COATED in 1 BOTTLE (33342-191-44)

source: ndc

Packages (4)

33342-191-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-191-07) 33342-191-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-191-10) 33342-191-12 10 BLISTER PACK in 1 CARTON (33342-191-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-191-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-191-44)

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": "bd687a21-be18-439a-8e65-103a15b4a8f8", "openfda": {"upc": ["0333342192073", "0333342191076", "0333342192103", "0333342190079", "0333342193100", "0333342191106", "0333342193070", "0333342190109"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["c86a3c45-c906-46c9-9f7b-6c3d89bbe48f"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-191-07)", "package_ndc": "33342-191-07", "marketing_start_date": "20161027"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-191-10)", "package_ndc": "33342-191-10", "marketing_start_date": "20161027"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-191-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-191-12", "marketing_start_date": "20161027"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-191-44)", "package_ndc": "33342-191-44", "marketing_start_date": "20161027"}], "brand_name": "AMLODIPINE and OLMESARTAN medoxomil", "product_id": "33342-191_bd687a21-be18-439a-8e65-103a15b4a8f8", "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": "33342-191", "generic_name": "AMLODIPINE and OLMESARTAN medoxomil", "labeler_name": "Macleods Pharmaceuticals 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": "40 mg/1"}], "application_number": "ANDA206884", "marketing_category": "ANDA", "marketing_start_date": "20161027", "listing_expiration_date": "20271231"}