olmesartan medoxomil and hydrochlorothiazide

Generic: olmesartan medoxomil and hydrochlorothiazide

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

Drug Facts

Product Profile

Brand Name olmesartan medoxomil and hydrochlorothiazide
Generic Name olmesartan medoxomil and hydrochlorothiazide
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-150
Product ID 46708-150_b993c27f-9ada-45be-bb55-245e11564d83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204233
Listing Expiration 2026-12-31
Marketing Start 2017-04-24

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 46708150
Hyphenated Format 46708-150

Supplemental Identifiers

RxCUI
403853 403854 403855
UPC
0346708149307 0346708151300 0346708150303
UNII
0J48LPH2TH 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 hydrochlorothiazide (source: ndc)
Generic Name olmesartan medoxomil and hydrochlorothiazide (source: ndc)
Application Number ANDA204233 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 80 TABLET in 1 CARTON (46708-150-08)
  • 100 TABLET in 1 CARTON (46708-150-10)
  • 30 TABLET in 1 BOTTLE (46708-150-30)
  • 90 TABLET in 1 BOTTLE (46708-150-90)
  • 1000 TABLET in 1 BOTTLE (46708-150-91)
source: ndc

Packages (5)

46708-150-08 80 TABLET in 1 CARTON (46708-150-08) 46708-150-10 100 TABLET in 1 CARTON (46708-150-10) 46708-150-30 30 TABLET in 1 BOTTLE (46708-150-30) 46708-150-90 90 TABLET in 1 BOTTLE (46708-150-90) 46708-150-91 1000 TABLET in 1 BOTTLE (46708-150-91)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) olmesartan medoxomil (40 mg/1)

Linked Drug Pages (1)

Olmesartan Medoxomil and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b993c27f-9ada-45be-bb55-245e11564d83", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0346708149307", "0346708151300", "0346708150303"], "unii": ["0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["403853", "403854", "403855"], "spl_set_id": ["8c65d555-8db8-40d9-be30-309ef09f19be"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "80 TABLET in 1 CARTON (46708-150-08)", "package_ndc": "46708-150-08", "marketing_start_date": "20170424"}, {"sample": false, "description": "100 TABLET in 1 CARTON (46708-150-10)", "package_ndc": "46708-150-10", "marketing_start_date": "20170424"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-150-30)", "package_ndc": "46708-150-30", "marketing_start_date": "20170424"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (46708-150-90)", "package_ndc": "46708-150-90", "marketing_start_date": "20170424"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-150-91)", "package_ndc": "46708-150-91", "marketing_start_date": "20170424"}], "brand_name": "Olmesartan Medoxomil and Hydrochlorothiazide", "product_id": "46708-150_b993c27f-9ada-45be-bb55-245e11564d83", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "46708-150", "generic_name": "Olmesartan Medoxomil and Hydrochlorothiazide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olmesartan Medoxomil and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA204233", "marketing_category": "ANDA", "marketing_start_date": "20170424", "listing_expiration_date": "20261231"}