amlodipine and olmesartan medoxomil (42291-001)

Drug Facts

Product Profile

Brand Name amlodipine and olmesartan medoxomil

Generic Name amlodipine and olmesartan medoxomil

Labeler avkare

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

AvKARE

Identifiers & Regulatory

Product NDC 42291-001

Product ID 42291-001_48480a71-5c94-91ab-e063-6294a90a656d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209010

Listing Expiration 2027-12-31

Marketing Start 2024-06-18

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 42291001

Hyphenated Format 42291-001

Supplemental Identifiers

RxCUI

730861 730866 730869 730872

UPC

0342291003309 0342291002302 0342291004306 0342291001305

UNII

864V2Q084H 6M97XTV3HD

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
20 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (42291-001-30)

source: ndc

Packages (1)

42291-001-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-001-30)

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": "48480a71-5c94-91ab-e063-6294a90a656d", "openfda": {"upc": ["0342291003309", "0342291002302", "0342291004306", "0342291001305"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["1b30c3fe-5c84-0d42-e063-6394a90a81d8"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42291-001-30)", "package_ndc": "42291-001-30", "marketing_start_date": "20240618"}], "brand_name": "Amlodipine and Olmesartan Medoxomil", "product_id": "42291-001_48480a71-5c94-91ab-e063-6294a90a656d", "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": "42291-001", "generic_name": "Amlodipine and Olmesartan Medoxomil", "labeler_name": "AvKARE", "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": "ANDA209010", "marketing_category": "ANDA", "marketing_start_date": "20240618", "listing_expiration_date": "20271231"}