amlodipine besylate and olmesartran medoxomil (46708-214)

Drug Facts

Product Profile

Brand Name amlodipine besylate and olmesartran medoxomil

Generic Name amlodipine besylate and olmesartran medoxomil

Labeler alembic pharmaceuticals limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amlodipine besylate 10 mg/1, olmesartan medoxomil 20 mg/1

Manufacturer

Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-214

Product ID 46708-214_cbb564d2-add9-430a-a36b-45147d417138

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 46708214

Hyphenated Format 46708-214

Supplemental Identifiers

RxCUI

730861 730866 730869 730872

UPC

0346708214302 0346708212308 0346708215309 0346708213305

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

10 mg/1
20 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (46708-214-30)
90 TABLET, FILM COATED in 1 BOTTLE (46708-214-90)
1000 TABLET, FILM COATED in 1 BOTTLE (46708-214-91)

source: ndc

Packages (3)

46708-214-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-214-30) 46708-214-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-214-90) 46708-214-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-214-91)

Ingredients (2)

amlodipine besylate (10 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": "cbb564d2-add9-430a-a36b-45147d417138", "openfda": {"upc": ["0346708214302", "0346708212308", "0346708215309", "0346708213305"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["cb2df7f7-fee8-42ba-8936-0788c4fcc0cb"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-214-30)", "package_ndc": "46708-214-30", "marketing_start_date": "20170718"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-214-90)", "package_ndc": "46708-214-90", "marketing_start_date": "20170718"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-214-91)", "package_ndc": "46708-214-91", "marketing_start_date": "20170718"}], "brand_name": "Amlodipine besylate and Olmesartran medoxomil", "product_id": "46708-214_cbb564d2-add9-430a-a36b-45147d417138", "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": "46708-214", "generic_name": "Amlodipine besylate and Olmesartran medoxomil", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine besylate and Olmesartran medoxomil", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "20 mg/1"}], "application_number": "ANDA207073", "marketing_category": "ANDA", "marketing_start_date": "20170718", "listing_expiration_date": "20261231"}