olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide

Generic: olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
Generic Name olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
Labeler slate run pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, hydrochlorothiazide 12.5 mg/1, olmesartan medoxomil 20 mg/1

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-014
Product ID 70436-014_d306cb9e-4244-49dd-9297-9cb6ca69cae9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210718
Listing Expiration 2026-12-31
Marketing Start 2025-05-15

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 70436014
Hyphenated Format 70436-014

Supplemental Identifiers

RxCUI
999967 999986 999991 999996 1000001
UPC
0370436018048 0370436016044 0370436014040 0370436015047 0370436017041
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 and amlodipine besylate and hydrochlorothiazide (source: ndc)
Generic Name olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide (source: ndc)
Application Number ANDA210718 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 12.5 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70436-014-04)
  • 90 TABLET, FILM COATED in 1 BOTTLE (70436-014-06)
source: ndc

Packages (2)

70436-014-04 30 TABLET, FILM COATED in 1 BOTTLE (70436-014-04) 70436-014-06 90 TABLET, FILM COATED in 1 BOTTLE (70436-014-06)

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (12.5 mg/1) olmesartan medoxomil (20 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d306cb9e-4244-49dd-9297-9cb6ca69cae9", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0370436018048", "0370436016044", "0370436014040", "0370436015047", "0370436017041"], "unii": ["0J48LPH2TH", "864V2Q084H", "6M97XTV3HD"], "rxcui": ["999967", "999986", "999991", "999996", "1000001"], "spl_set_id": ["a469adff-25a6-4983-b471-60924d920a86"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70436-014-04)", "package_ndc": "70436-014-04", "marketing_start_date": "20250515"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70436-014-06)", "package_ndc": "70436-014-06", "marketing_start_date": "20250515"}], "brand_name": "olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide", "product_id": "70436-014_d306cb9e-4244-49dd-9297-9cb6ca69cae9", "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": "70436-014", "generic_name": "olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "20 mg/1"}], "application_number": "ANDA210718", "marketing_category": "ANDA", "marketing_start_date": "20250515", "listing_expiration_date": "20261231"}