losartan potassium and hydrochlorothiazide (68788-8510)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler preferred pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, losartan potassium 50 mg/1

Manufacturer

Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8510

Product ID 68788-8510_55b99e30-0b39-4e66-941c-fcd32fda827c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078245

Listing Expiration 2026-12-31

Marketing Start 2023-08-22

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 687888510

Hyphenated Format 68788-8510

Supplemental Identifiers

RxCUI

979468

UNII

0J48LPH2TH 3ST302B24A

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 losartan potassium and hydrochlorothiazide (source: ndc)

Generic Name losartan potassium and hydrochlorothiazide (source: ndc)

Application Number ANDA078245 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
50 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (68788-8510-1)
30 TABLET in 1 BOTTLE (68788-8510-3)
60 TABLET in 1 BOTTLE (68788-8510-6)
90 TABLET in 1 BOTTLE (68788-8510-9)

source: ndc

Packages (4)

68788-8510-1 100 TABLET in 1 BOTTLE (68788-8510-1) 68788-8510-3 30 TABLET in 1 BOTTLE (68788-8510-3) 68788-8510-6 60 TABLET in 1 BOTTLE (68788-8510-6) 68788-8510-9 90 TABLET in 1 BOTTLE (68788-8510-9)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) losartan potassium (50 mg/1)

Linked Drug Pages (1)

Losartan Potassium and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "55b99e30-0b39-4e66-941c-fcd32fda827c", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979468"], "spl_set_id": ["0f0c7234-b605-440f-abed-44f992d189a2"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8510-1)", "package_ndc": "68788-8510-1", "marketing_start_date": "20230822"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8510-3)", "package_ndc": "68788-8510-3", "marketing_start_date": "20230822"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8510-6)", "package_ndc": "68788-8510-6", "marketing_start_date": "20230822"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8510-9)", "package_ndc": "68788-8510-9", "marketing_start_date": "20230822"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "68788-8510_55b99e30-0b39-4e66-941c-fcd32fda827c", "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": "68788-8510", "generic_name": "Losartan Potassium and Hydrochlorothiazide", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Losartan Potassium and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "LOSARTAN POTASSIUM", "strength": "50 mg/1"}], "application_number": "ANDA078245", "marketing_category": "ANDA", "marketing_start_date": "20230822", "listing_expiration_date": "20261231"}