azor

Generic: amlodipine besylate and olmesartan medoxomil

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name azor
Generic Name amlodipine besylate and olmesartan medoxomil
Labeler cosette pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0872
Product ID 0713-0872_00491aef-cf0c-eeb3-e063-6394a90a716d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022100
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

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 07130872
Hyphenated Format 0713-0872

Supplemental Identifiers

RxCUI
730861 730866 730869 730872 744624 744628 744632 744636
UPC
0307130871303 0307130873307 0307130872300 0307130870306
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 azor (source: ndc)
Generic Name amlodipine besylate and olmesartan medoxomil (source: ndc)
Application Number NDA022100 (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, PLASTIC (0713-0872-30)
source: ndc

Packages (1)

0713-0872-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0872-30)

Ingredients (2)

amlodipine besylate (5 mg/1) olmesartan medoxomil (40 mg/1)

Linked Drug Pages (1)

Azor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00491aef-cf0c-eeb3-e063-6394a90a716d", "openfda": {"upc": ["0307130871303", "0307130873307", "0307130872300", "0307130870306"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872", "744624", "744628", "744632", "744636"], "spl_set_id": ["c5535406-b63b-49aa-88b9-169aaf0ed08e"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0872-30)", "package_ndc": "0713-0872-30", "marketing_start_date": "20220901"}], "brand_name": "Azor", "product_id": "0713-0872_00491aef-cf0c-eeb3-e063-6394a90a716d", "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": "0713-0872", "generic_name": "amlodipine besylate and olmesartan medoxomil", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azor", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "NDA022100", "marketing_category": "NDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}