amlodipine and olmesartan medoxomil

Generic: amlodipine and olmesartan medoxomil

Labeler: micro labs limited
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 micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-237
Product ID 42571-237_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 42571237
Hyphenated Format 42571-237

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
  • 5 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (42571-237-05)
  • 1000 TABLET in 1 BOTTLE (42571-237-10)
  • 30 TABLET in 1 BOTTLE (42571-237-30)
  • 90 TABLET in 1 BOTTLE (42571-237-90)
source: ndc

Packages (4)

42571-237-05 500 TABLET in 1 BOTTLE (42571-237-05) 42571-237-10 1000 TABLET in 1 BOTTLE (42571-237-10) 42571-237-30 30 TABLET in 1 BOTTLE (42571-237-30) 42571-237-90 90 TABLET in 1 BOTTLE (42571-237-90)

Ingredients (2)

amlodipine besylate (5 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 (42571-237-05)", "package_ndc": "42571-237-05", "marketing_start_date": "20180101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (42571-237-10)", "package_ndc": "42571-237-10", "marketing_start_date": "20180101"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-237-30)", "package_ndc": "42571-237-30", "marketing_start_date": "20180101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42571-237-90)", "package_ndc": "42571-237-90", "marketing_start_date": "20180101"}], "brand_name": "AMLODIPINE AND OLMESARTAN MEDOXOMIL", "product_id": "42571-237_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": "42571-237", "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": "5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA207435", "marketing_category": "ANDA", "marketing_start_date": "20180101", "listing_expiration_date": "20261231"}