losartan potassium and hydrochlorothiazide (70010-188)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler granules pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, losartan potassium 100 mg/1

Manufacturer

Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-188

Product ID 70010-188_1cb60a8e-0849-4a3e-e063-6294a90a350e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA218015

Listing Expiration 2026-12-31

Marketing Start 2023-09-29

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 70010188

Hyphenated Format 70010-188

Supplemental Identifiers

RxCUI

979464 979468 979471

UPC

0370010188037 0370010189034

UNII

0J48LPH2TH 3ST302B24A

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 losartan potassium and hydrochlorothiazide (source: ndc)

Generic Name losartan potassium and hydrochlorothiazide (source: ndc)

Application Number ANDA218015 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
100 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (70010-188-03)
1000 TABLET, FILM COATED in 1 BOTTLE (70010-188-10)

source: ndc

Packages (2)

70010-188-03 30 TABLET, FILM COATED in 1 BOTTLE (70010-188-03) 70010-188-10 1000 TABLET, FILM COATED in 1 BOTTLE (70010-188-10)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) losartan potassium (100 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": "1cb60a8e-0849-4a3e-e063-6294a90a350e", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0370010188037", "0370010189034"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["b4168479-09ec-402c-89cc-456bc8485017"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70010-188-03)", "package_ndc": "70010-188-03", "marketing_start_date": "20230929"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70010-188-10)", "package_ndc": "70010-188-10", "marketing_start_date": "20230929"}], "brand_name": "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE", "product_id": "70010-188_1cb60a8e-0849-4a3e-e063-6294a90a350e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "70010-188", "generic_name": "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE", "labeler_name": "Granules 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": "100 mg/1"}], "application_number": "ANDA218015", "marketing_category": "ANDA", "marketing_start_date": "20230929", "listing_expiration_date": "20261231"}