olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Generic: olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Labeler: endo usa, 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 endo usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1, hydrochlorothiazide 12.5 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-789
Product ID 49884-789_64db5fb3-c133-422f-9cf5-98e60d98bdc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206137
Listing Expiration 2026-12-31
Marketing Start 2016-10-26

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 49884789
Hyphenated Format 49884-789

Supplemental Identifiers

RxCUI
999967 999986 999991 999996 1000001
UPC
0349884787097 0349884788094 0349884786090 0349884789091 0349884790097
UNII
0J48LPH2TH 864V2Q084H 6M97XTV3HD
NUI
N0000175359 N0000175419 M0471776

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 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
  • 10 mg/1
  • 12.5 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (49884-789-09)
  • 30 TABLET, FILM COATED in 1 BOTTLE (49884-789-11)
source: ndc

Packages (2)

49884-789-09 90 TABLET, FILM COATED in 1 BOTTLE (49884-789-09) 49884-789-11 30 TABLET, FILM COATED in 1 BOTTLE (49884-789-11)

Ingredients (3)

amlodipine besylate (10 mg/1) hydrochlorothiazide (12.5 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": "64db5fb3-c133-422f-9cf5-98e60d98bdc4", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0349884787097", "0349884788094", "0349884786090", "0349884789091", "0349884790097"], "unii": ["0J48LPH2TH", "864V2Q084H", "6M97XTV3HD"], "rxcui": ["999967", "999986", "999991", "999996", "1000001"], "spl_set_id": ["268d12e8-1cfc-4086-b613-8fd94f2d7c4e"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (49884-789-09)", "package_ndc": "49884-789-09", "marketing_start_date": "20161026"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (49884-789-11)", "package_ndc": "49884-789-11", "marketing_start_date": "20161026"}], "brand_name": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "product_id": "49884-789_64db5fb3-c133-422f-9cf5-98e60d98bdc4", "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": "49884-789", "generic_name": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA206137", "marketing_category": "ANDA", "marketing_start_date": "20161026", "listing_expiration_date": "20261231"}