amlodipine and olmesartan medoxomil (42571-238)

Drug Facts

Product Profile

Brand Name amlodipine and olmesartan medoxomil

Generic Name amlodipine and olmesartan medoxomil

Labeler micro labs limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

amlodipine besylate 10 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer

Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-238

Product ID 42571-238_2b531912-67b1-6172-e063-6394a90a178f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207435

Listing Expiration 2026-12-31

Marketing Start 2018-01-01

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 42571238

Hyphenated Format 42571-238

Supplemental Identifiers

RxCUI

730861 730866 730869 730872

UPC

0342571238308 0342571237301 0342571235307 0342571236304

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 ANDA207435 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
40 mg/1

source: ndc

Packaging

500 TABLET in 1 BOTTLE (42571-238-05)
1000 TABLET in 1 BOTTLE (42571-238-10)
30 TABLET in 1 BOTTLE (42571-238-30)
90 TABLET in 1 BOTTLE (42571-238-90)

source: ndc

Packages (4)

42571-238-05 500 TABLET in 1 BOTTLE (42571-238-05) 42571-238-10 1000 TABLET in 1 BOTTLE (42571-238-10) 42571-238-30 30 TABLET in 1 BOTTLE (42571-238-30) 42571-238-90 90 TABLET in 1 BOTTLE (42571-238-90)

Ingredients (2)

amlodipine besylate (10 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": "2b531912-67b1-6172-e063-6394a90a178f", "openfda": {"upc": ["0342571238308", "0342571237301", "0342571235307", "0342571236304"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["7fcf6a87-7b3e-4cef-8c47-c8a008cfea82"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-238-05)", "package_ndc": "42571-238-05", "marketing_start_date": "20180101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (42571-238-10)", "package_ndc": "42571-238-10", "marketing_start_date": "20180101"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-238-30)", "package_ndc": "42571-238-30", "marketing_start_date": "20180101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42571-238-90)", "package_ndc": "42571-238-90", "marketing_start_date": "20180101"}], "brand_name": "AMLODIPINE AND OLMESARTAN MEDOXOMIL", "product_id": "42571-238_2b531912-67b1-6172-e063-6394a90a178f", "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": "42571-238", "generic_name": "Amlodipine and Olmesartan Medoxomil", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE AND OLMESARTAN MEDOXOMIL", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA207435", "marketing_category": "ANDA", "marketing_start_date": "20180101", "listing_expiration_date": "20261231"}