amlodipine and olmesartan medoxomil

Generic: amlodipine and olmesartan medoxomil

Labeler: sciegen pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
ScieGen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50228-368
Product ID 50228-368_1666c9c9-9d30-4155-e063-6394a90afde9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209010
Listing Expiration 2026-12-31
Marketing Start 2018-12-03

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 50228368
Hyphenated Format 50228-368

Supplemental Identifiers

RxCUI
730861 730866 730869 730872
UPC
0350228367103 0350228367301 0350228366106 0350228365109 0350228368100 0350228366908 0350228365307 0350228366304 0350228368902 0350228365901 0350228368308 0350228367905
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 ANDA209010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50228-368-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-368-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50228-368-90)
source: ndc

Packages (3)

50228-368-10 1000 TABLET, FILM COATED in 1 BOTTLE (50228-368-10) 50228-368-30 30 TABLET, FILM COATED in 1 BOTTLE (50228-368-30) 50228-368-90 90 TABLET, FILM COATED in 1 BOTTLE (50228-368-90)

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": "1666c9c9-9d30-4155-e063-6394a90afde9", "openfda": {"upc": ["0350228367103", "0350228367301", "0350228366106", "0350228365109", "0350228368100", "0350228366908", "0350228365307", "0350228366304", "0350228368902", "0350228365901", "0350228368308", "0350228367905"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["c531fceb-09aa-492b-a5a3-2b004e9eadda"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-368-10)", "package_ndc": "50228-368-10", "marketing_start_date": "20181203"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-368-30)", "package_ndc": "50228-368-30", "marketing_start_date": "20181203"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50228-368-90)", "package_ndc": "50228-368-90", "marketing_start_date": "20181203"}], "brand_name": "Amlodipine and Olmesartan Medoxomil", "product_id": "50228-368_1666c9c9-9d30-4155-e063-6394a90afde9", "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": "50228-368", "generic_name": "Amlodipine and Olmesartan Medoxomil", "labeler_name": "ScieGen Pharmaceuticals, Inc", "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": "ANDA209010", "marketing_category": "ANDA", "marketing_start_date": "20181203", "listing_expiration_date": "20261231"}