olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Generic: olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

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

Drug Facts

Product Profile

Brand Name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Generic Name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, hydrochlorothiazide 25 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4165
Product ID 70518-4165_47cc41df-209b-9d3e-e063-6394a90a5c91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206137
Listing Expiration 2027-12-31
Marketing Start 2024-08-22

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184165
Hyphenated Format 70518-4165

Supplemental Identifiers

RxCUI
1000001
UNII
864V2Q084H 0J48LPH2TH 6M97XTV3HD
NUI
N0000175359 N0000175419 M0471776

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 olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide (source: ndc)
Generic Name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide (source: ndc)
Application Number ANDA206137 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 25 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4165-0)
source: ndc

Packages (1)

70518-4165-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4165-0)

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (25 mg/1) olmesartan medoxomil (40 mg/1)

Linked Drug Pages (1)

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47cc41df-209b-9d3e-e063-6394a90a5c91", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["864V2Q084H", "0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["1000001"], "spl_set_id": ["57ffeef7-bfa8-4f92-aadc-23cd00022607"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4165-0)", "package_ndc": "70518-4165-0", "marketing_start_date": "20240822"}], "brand_name": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "product_id": "70518-4165_47cc41df-209b-9d3e-e063-6394a90a5c91", "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]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "70518-4165", "generic_name": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA206137", "marketing_category": "ANDA", "marketing_start_date": "20240822", "listing_expiration_date": "20271231"}