amlodipine besylate and olmesartran medoxomil

Generic: amlodipine besylate and olmesartran medoxomil

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-212
Product ID 62332-212_fe578906-d9fc-4f00-9de4-8e02292ad1c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207073
Listing Expiration 2026-12-31
Marketing Start 2017-07-18

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 62332212
Hyphenated Format 62332-212

Supplemental Identifiers

RxCUI
730861 730866 730869 730872
UPC
0362332213306 0362332215300 0362332212309 0362332214303
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 olmesartran medoxomil (source: ndc)
Generic Name amlodipine besylate and olmesartran medoxomil (source: ndc)
Application Number ANDA207073 (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 (62332-212-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (62332-212-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62332-212-91)
source: ndc

Packages (3)

62332-212-30 30 TABLET, FILM COATED in 1 BOTTLE (62332-212-30) 62332-212-90 90 TABLET, FILM COATED in 1 BOTTLE (62332-212-90) 62332-212-91 1000 TABLET, FILM COATED in 1 BOTTLE (62332-212-91)

Ingredients (2)

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

Linked Drug Pages (1)

Amlodipine besylate and Olmesartran medoxomil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fe578906-d9fc-4f00-9de4-8e02292ad1c0", "openfda": {"upc": ["0362332213306", "0362332215300", "0362332212309", "0362332214303"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["1eb78d80-701d-4766-98c3-feee6790de1a"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62332-212-30)", "package_ndc": "62332-212-30", "marketing_start_date": "20170718"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62332-212-90)", "package_ndc": "62332-212-90", "marketing_start_date": "20170718"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62332-212-91)", "package_ndc": "62332-212-91", "marketing_start_date": "20170718"}], "brand_name": "Amlodipine besylate and Olmesartran medoxomil", "product_id": "62332-212_fe578906-d9fc-4f00-9de4-8e02292ad1c0", "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": "62332-212", "generic_name": "Amlodipine besylate and Olmesartran medoxomil", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine besylate and Olmesartran medoxomil", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "20 mg/1"}], "application_number": "ANDA207073", "marketing_category": "ANDA", "marketing_start_date": "20170718", "listing_expiration_date": "20261231"}