amlodipine besylate and olmesartan medoxomil (27241-083)

Drug Facts

Product Profile

Brand Name amlodipine besylate and olmesartan medoxomil

Generic Name amlodipine besylate and olmesartan medoxomil

Labeler ajanta pharma usa inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-083

Product ID 27241-083_1c06acbb-7027-4b05-90a0-4f40c039c705

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207216

Listing Expiration 2027-12-31

Marketing Start 2017-02-06

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 27241083

Hyphenated Format 27241-083

Supplemental Identifiers

RxCUI

730861 730866 730869 730872

UPC

0327241085031 0327241083037 0327241084034 0327241086038

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 besylate and olmesartan medoxomil (source: ndc)

Generic Name amlodipine besylate and olmesartan medoxomil (source: ndc)

Application Number ANDA207216 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
20 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (27241-083-03)
90 TABLET in 1 BOTTLE (27241-083-09)

source: ndc

Packages (2)

27241-083-03 30 TABLET in 1 BOTTLE (27241-083-03) 27241-083-09 90 TABLET in 1 BOTTLE (27241-083-09)

Ingredients (2)

amlodipine besylate (5 mg/1) olmesartan medoxomil (20 mg/1)

Linked Drug Pages (1)

Amlodipine besylate and Olmesartan medoxomil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1c06acbb-7027-4b05-90a0-4f40c039c705", "openfda": {"upc": ["0327241085031", "0327241083037", "0327241084034", "0327241086038"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["69fa6293-b10a-4473-ab9b-1bd53f099bdd"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (27241-083-03)", "package_ndc": "27241-083-03", "marketing_start_date": "20170206"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (27241-083-09)", "package_ndc": "27241-083-09", "marketing_start_date": "20170206"}], "brand_name": "Amlodipine besylate and Olmesartan medoxomil", "product_id": "27241-083_1c06acbb-7027-4b05-90a0-4f40c039c705", "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": "27241-083", "generic_name": "Amlodipine besylate and Olmesartan medoxomil", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine besylate and Olmesartan medoxomil", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "20 mg/1"}], "application_number": "ANDA207216", "marketing_category": "ANDA", "marketing_start_date": "20170206", "listing_expiration_date": "20271231"}