Home › NDC Lookup › Ingredients › Losartan Potassium And Hydrochlorothiazi... › 68180-0217-06

Losartan Potassium and Hydrochlorothiazide 25 mg; 100 mg Tablet, 30-count

by Lupin Pharmaceuticals, Inc. · 30 TABLET in 1 BOTTLE (68180-217-06)

NDC 68180-0217-06

🏷️ FDA NDC (as labeled) 68180-217-06 billing pads the product segment with a zero

This package

Contains30-count Cost per ea$0.0783 NADAC Per package$2.35 / 30 tablets Pack sizes4 compare ↓

Also priced by: Medicaid pays $0.2618/unit · Part D plans $0.1658/unit — full pricing hub ↓

Also comes in: 90 tablets 68180-0217-09 100 tablets 68180-0217-01 1000 tablets 68180-0217-03

Rx only Generic On market Non-controlled

🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Losartan Potassium And Hydrochlorothiazide (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · May 7, 2024 — Presence of foreign substance: plastic-like substance. (MACLEODS PHARMA USA, INC) · FDA recall D-0498-2024

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Past resolved recalls for this product (3)

Class II · Mar 31, 2022 · Terminated — CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits (Lupin Pharmaceuticals Inc.) · FDA recall D-0841-2022

Class II · Mar 31, 2022 · Terminated — CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits (Lupin Pharmaceuticals Inc.) · FDA recall D-0842-2022

Class II · Mar 31, 2022 · Terminated — CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits (Lupin Pharmaceuticals Inc.) · FDA recall D-0843-2022

🆔 Identity & classification

FDA NDC (as labeled) 68180-217-06

Product NDC 68180-217

11-digit billing NDC 68180021706

NCPDP billing unit EA — each (per item)

RxCUI 979464, 979468, 979471

UNII 3ST302B24A, 0J48LPH2TH

UPC 0368180215066, 0368180217060

Application # ANDA078245

SPL Set ID ee1eaaf6-050b-48af-942b-5e3451edc164

Established class (EPC) Thiazide Diuretic

Physiologic effect Increased Diuresis

Chemical class Thiazides

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2010-10-06

Route ORAL

Dosage form TABLET

Substance HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

GCN Seq No 040923

GCN 14854

HICL code 009863

Ingredient (HICL) Losartan/Hydrochlorothiazide

HIC1 code A

Therapeutic class — broad (HIC1) Cardiovascular System

HIC2 code A4

Therapeutic class — intermediate (HIC2) Antihypertensives

HIC3 code A4I

Therapeutic class — specific (HIC3) Angiotensin Receptor Antag.-Thiazide Diuretic Comb

AHFS code 24:32.08.00

AHFS class Angiotensin Ii Receptor Antagonists

FDB label name LOSARTAN-HCTZ 100-25 MG TAB

FDB brand name Losartan-Hydrochlorothiazide

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 68180-217-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68180-0217-06. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Angiotensin 2 Receptor Blocker class.

Pharmacologic class Angiotensin 2 Receptor Blocker

Drug family (ATC) Angiotensin II receptor blockers (ARBs), plain

How it works Angiotensin 2 Receptor Antagonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLupin Pharmaceuticals, Inc.

Application holderLUPIN LTD

FDA applicationANDA078245 (ANDA)

Labeler code68180

First marketedOct 2010

Product typeHuman Prescription Drug

Portfolio404 products on file

🔎 All NDCs from Lupin Pharmaceuticals, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LOSARTAN-HCTZ 100-25 MG TAB Ingredient Losartan/Hydrochlorothiazide

📖 What it is MedlinePlus · NLM

Hydrochlorothiazide is used alone or in combination with other medications to treat high blood pressure. Hydrochlorothiazide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, and liver disease and to treat edema caused by using certain medications including estrogen and corticosteroids. Hydrochlorothiazide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It's working in two ways at once to lower your blood pressure. Losartan relaxes your blood vessels by blocking a hormone called angiotensin II that would otherwise tighten them. Hy...
What exactly is this medication doing for me?
You can take it with or without food — a meal won't significantly change how well it works. Picking a consistent time each day (morning is common) helps you remember it and keeps y...
Can I take this with food, and does it matter what time of day I take it?

📖 Read our full Hydrochlorothiazide / Losartan guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow / White

ShapeTear

ImprintLU;M43

Size15 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.078	$2.35 / 30 tablets
Medicaid paysCMS SDUD · 12 mo	$0.2618	$7.85 / 30 tablets
Medicare drug plans payPart D · Q2 2026	$0.1658	$4.97 / 30 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 59% over the last 23 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 00093-7368-10	Teva	1000 tablets	$0.078	AB	Availability likely	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 16714-0225-01	NorthStar	30 tablets	$0.078	AB	Availability likely	—
Losartan potassium and Hydrochlorothiazide 100 mg/1; 25 mg 33342-0052-07	Macleods	30 tablets	$0.078	AB	Availability likely	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 43547-0424-03	Solco	30 tablets	$0.078	AB	Availability likely	—
Losartan Potassium and Hydrochlorothiazide 25 mg/1; 100 mgthis 68180-0217-06	Lupin	30 tablets	$0.078	AB	Availability likely	—
Hyzaar 100 mg/1; 25 mg 78206-0141-01	Organon	30 tablets	$6.832	AB	Availability likely	+8622%
losartan potassium and hydrochlorothiazide 25 mg/1; 100 mg 29300-0192-01	Unichem	100 tablets	—	AB	FDA listed	—
Losartan Potassium And Hydrochlorothiazide 100 mg/1; 25 mg 31722-0757-10	Camber	1000 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 42291-0504-90	AvKARE	90 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 46708-0450-10	Alembic	10 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 50090-1641-00	A-S	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 50090-4447-00	A-S	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 25 mg/1; 100 mg 50090-4993-00	A-S	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 50090-6636-00	A-S	90 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 50090-7058-00	A-S	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 50090-7059-00	A-S	90 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 50090-7199-00	A-S	90 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 25 mg/1; 100 mg 50090-7664-00	A-S	90 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 50090-7821-00	A-S	90 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 59746-0339-01	Jubilant	100 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 60760-0572-90	St.	90 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 62332-0050-10	Alembic	10 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 63187-0347-30	Proficient	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 63187-0602-30	Proficient	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 63629-2430-01	Bryant	1000 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 65862-0470-10	Aurobindo	10 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 68071-4518-03	NuCare	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 68788-6452-01	Preferred	100 tablets	—	AB	FDA listed	—
Losartan Potassium And Hydrochlorothiazide 100 mg/1; 25 mg 70010-0189-03	Granules	30 tablets	—	—	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 70518-2737-02	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 70518-3420-00	REMEDYREPACK	1 tablet	—	AB	Discontinued	—
Losartan Potassium and Hydrochlorothiazide 25 mg/1; 100 mg 71335-2558-01	Bryant	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 71335-2560-01	Bryant	30 tablets	—	AB	FDA listed	—
losartan potassium and hydrochlorothiazide 25 mg/1; 100 mg 71610-0671-30	Aphena	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 72162-1701-00	Bryant	1000 tablets	—	AB	FDA listed	—
Losartan Potassium And Hydrochlorothiazide 25 mg/1; 100 mg 72189-0139-30	Direct_Rx	30 tablets	—	AB	FDA listed	—
Losartan Potassium And Hydrochlorothiazide 25 mg/1; 100 mg 72189-0288-90	DirectRx	90 tablets	—	AB	FDA listed	—
Losartan Potassium And Hydrochlorothiazide 25 mg/1; 100 mg 72189-0289-90	DirectRx	90 tablets	—	AB	FDA listed	—
Losartan Potassium And Hydrochlorothiazide 100 mg/1; 25 mg 72189-0326-30	Direct	30 tablets	—	AB	FDA listed	—
Losartan Potassium and Hydrochlorothiazide 100 mg/1; 25 mg 83008-0086-90	Quality	90 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2010

On the market since

Oct 2010

📍

2026

Currently FDA-listed

16 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68180-0217-06, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

3.8K

Units reimbursed last 4 qtrs

181.1K

Gross reimbursed last 4 qtrs

$47.4K

Avg / prescription

$12.50

Avg / unit

$0.2618

Latest quarter Q4 2025

936Rx

Medicaid pays / ea

$0.2618

gross reimbursed

NADAC / ea

$0.0783

acquisition cost

Spread

+$0.1835

+234% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

35% FFS 65% MCO

Fee-for-service · 1,321 Rx Managed care · 2,473 Rx

State Medicaid map

Units reimbursed · per 100k residents

1.41,001

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 D.C. 1,001 /100k

2 Maryland 577 /100k

3 Maine 306 /100k

4 Connecticut 238 /100k

5 New York 230 /100k

6 Nebraska 194 /100k

7 New Hampshire 184 /100k

8 Virginia 143 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

90 tablets68180-0217-09 73,677 Rx · $994,745

30 tablets this page68180-0217-06 3,794 Rx · $47,408

100 tablets68180-0217-01 No Medicaid data

1000 tablets68180-0217-03 No Medicaid data

Drug total (last 4 qtrs): 77,471 Rx · 4,389,966 units · $1,042,152 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Losartan potassium and hydrochlorothiazide — the ingredient across all brands.

Top reported reactions

Nausea774

Fatigue688

Dizziness590

Headache563

Diarrhoea534

Dyspnoea512

Pain511

Reporter sex

Serious outcomes

Death698

Disabling469

Life-threatening425

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
68180-0217-01	100 TABLET in 1 BOTTLE (68180-217-01)	—	—	2010-10-06	Active
68180-0217-03	1000 TABLET in 1 BOTTLE (68180-217-03)	—	—	2010-10-06	Discontinued by firm
68180-0217-06 You're viewing this	30 TABLET in 1 BOTTLE (68180-217-06)	$0.0783 / ea	$2.35	2010-10-06	Active
68180-0217-09	90 TABLET in 1 BOTTLE (68180-217-09)	$0.0783 / ea	$7.05	2010-10-06	Active

You're viewing the smallest of 4 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0783 NADAC).

This pack accounts for about 4.9% of this product's recent Medicaid fills; most go to the 90 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 68180-0217-06?

NDC 68180-0217-06 is a 30-count package — 30 tablet in 1 bottle.

What is the difference between NDC 68180-0217-06 and NDC 68180-0217-09?

Both are Losartan Potassium and Hydrochlorothiazide 25 mg; 100 mg Tablet — the drug itself is identical. NDC 68180-0217-06 is the 30-count package, while NDC 68180-0217-09 is the 90 tablets package.

What NDC number is used to bill for this package of Losartan Potassium and Hydrochlorothiazide 25 mg; 100 mg Tablet?

Bill NDC 68180-0217-06 — the 11-digit billing format is 68180021706. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🚨 Boxed Warning 86 words ▾

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNINGS AND PRECAUTIONS ( 5.1 )]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Losartan potassium and hydrochlorothiazide tablet is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.

There is evidence that this benefit does not apply to Black patients. ( 1.2 )

1.1Hypertension Losartan potassium and hydrochlorothiazide tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan and hydrochlorothiazide.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients [see CLINICAL STUDIES ( 14 ) and DOSAGE AND ADMINISTRATION ( 2.1 )].

Losartan potassium and hydrochlorothiazide tablet may be administered with other antihypertensive agents.

1.2Hypertensive Patients with Left Ventricular Hypertrophy Losartan potassium and hydrochlorothiazide tablet is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. [See USE IN SPECIFIC POPULATIONS ( 8.6 ), CLINICAL PHARMACOLOGY ( 12.3 ), and DOSAGE AND ADMINISTRATION ( 2.2 ).]

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Hypertension Usual starting dose: 50/12.5 mg once daily. ( 2.1 ) Titrate as needed to a maximum dose of 100/25 mg. ( 2.1 ) Hypertensive Patients with Left Ventricular Hypertrophy Not controlled on monotherapy: Initiate with 50/12.5 mg. Titrate as needed to a maximum of 100/25 mg. ( 2.2 )

2.1Hypertension The usual starting dose of losartan potassium and hydrochlorothiazide tablet is 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily as needed to control blood pressure [see CLINICAL STUDIES ( 14.2 )]. Initiate a patient whose blood pressure is not adequately controlled with losartan 50 mg monotherapy with losartan potassium and hydrochlorothiazide tablet 50/12.5 once daily.

If blood pressure remains uncontrolled after about 3 weeks of therapy, the dosage may be increased to two tablets of losartan potassium and hydrochlorothiazide tablet 50/12.5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablet 100/25 once daily. Initiate a patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy with losartan potassium and hydrochlorothiazide tablet 100/12.5 (losartan 100 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of losartan potassium and hydrochlorothiazide tablet 50/12.5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablet 100/25 once daily.

Initiate a patient whose blood pressure is inadequately controlled with hydrochlorothiazide 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen, on losartan potassium and hydrochlorothiazide tablet 50/12.5 once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. Evaluate the clinical response to losartan potassium and hydrochlorothiazide tablet 50/12.5 and, if blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of losartan potassium and hydrochlorothiazide tablet 50/12.5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablet 100/25 once daily.

2.2Hypertensive Patients with Left Ventricular Hypertrophy In patients whose blood pressure is not adequately controlled on 50 mg losartan potassium, initiate treatment with losartan potassium and hydrochlorothiazide tablet 50/12.5. If additional blood pressure reduction is needed, increase the dose to losartan potassium and hydrochlorothiazide tablet 100/12.5, followed by losartan potassium and hydrochlorothiazide tablet 100/25. For further blood pressure reduction add other antihypertensives [see CLINICAL STUDIES ( 14 )].

💊 Dosage Forms and Strengths 105 words ▾

3 DOSAGE FORMS AND STRENGTHS Losartan potassium and hydrochlorothiazide tablets USP 50 mg/12.5 mg are yellow, capsule shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'M41' on the other side. Losartan potassium and hydrochlorothiazide tablets USP 100 mg/12.5 mg are white, oval shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'M42' on the other side. Losartan potassium and hydrochlorothiazide tablets USP 100 mg /25 mg are yellow, tear drop shaped, biconvex, film-coated tablets, debossed with 'LU' on one side and 'M43' on the other side.

Tablets (losartan potassium/hydrochlorothiazide content): 50/12.5 mg; 100/12.5 mg; and 100/25 mg. ( 3 )

⛔ Contraindications 59 words ▾

4 CONTRAINDICATIONS Losartan potassium and hydrochlorothiazide tablet is contraindicated: In patients who are hypersensitive to any component of this product. In patients with anuria For coadministration with aliskiren in patients with diabetes Hypersensitivity to any component of losartan potassium and hydrochlorothiazide tablets. ( 4 ) Anuria. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume or salt depletion prior to administration of losartan potassium and hydrochlorothiazide tablets. ( 5.2 ) Monitor renal function and potassium in susceptible patients. ( 5.3 ) Observe for clinical signs of fluid or electrolyte imbalance. ( 5.5 ) Acute angle-closure glaucoma. ( 5.6 ) Exacerbation of systemic lupus erythematosus. ( 5.7 )

5.1Fetal Toxicity Losartan potassium and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible. Thiazides cross the placental barrier and appear in cord blood.

Adverse reactions include fetal or neonatal jaundice, thrombocytopenia [see USE IN SPECIFIC POPULATIONS ( 8.1 )].

5.2Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with losartan potassium and hydrochlorothiazide tablets. Correct volume or salt depletion prior to administration of losartan potassium and hydrochlorothiazide tablets. Do not use losartan potassium and hydrochlorothiazide tablets as initial therapy in patients with intravascular volume depletion.

5.3Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on losartan potassium and hydrochlorothiazide tablets .Monitor renal function periodically in these patients.

Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on losartan potassium and hydrochlorothiazide tablets [see DRUG INTERACTIONS ( 7.3 ) and USE IN SPECIFIC POPULATIONS ( 8.8 )].

5.4Hypersensitivity Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma but are more likely in patients with such a history [see ADVERSE REACTIONS ( 6.2 )] .

5.5Electrolyte and Metabolic Effects In double-blind clinical trials of various doses of losartan potassium and hydrochlorothiazide, the incidence of hypertensive patients who developed hypokalemia (serum potassium <3.5 mEq/L) was 6.7% versus 3.5% for placebo; the incidence of hyperkalemia (serum potassium >5.7 mEq/L) was 0.4% versus 0% for placebo. Losartan potassium and hydrochlorothiazide tablet contains hydrochlorothiazide which can cause hypokalemia, hyponatremia and hypomagnesemia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion.

Losartan potassium and hydrochlorothiazide tablet also contains losartan which can cause hyperkalemia. Monitor serum electrolytes periodically [see DRUG INTERACTIONS ( 7.1 )]. Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia [see DRUG INTERACTIONS ( 7.1 )].

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy. Because losartan decreases uric acid, losartan in combination with hydrochlorothia…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2% and greater than placebo) are dizziness, upper respiratory infection, cough, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Losartan potassium-hydrochlorothiazide has been evaluated for safety in 858 patients treated for essential hypertension and 3889 patients treated for hypertension and left ventricular hypertrophy. Most adverse reactions have been mild and transient in nature and have not required discontinuation of therapy.

In controlled clinical trials, discontinuation of therapy due to clinical adverse events was required in only 2.8% and 2.3% of patients treated with the combination and placebo, respectively. In these double-blind controlled clinical trials, adverse reactions occurring in greater than 2% of subjects treated with losartan-hydrochlorothiazide and at a greater rate than placebo were: back pain (2.1% vs 0.6%), dizziness (5.7% vs 2.9%), and upper respiratory infection (6.1% vs 4.6%). The following additional adverse reactions have been reported in clinical trials with losartan potassium and hydrochlorothiazide tablets and/or the individual components: Blood and the Lymphatic System Disorders Anemia, aplastic anemia, hemolytic anemia, leukopenia, agranulocytosis.

Metabolism and Nutrition Disorders Anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance including hyponatremia and hypokalemia. Psychiatric Disorders Insomnia, restlessness. Nervous System Disorders Dysgeusia, headache, migraine, paraesthesias.

Eye Disorders Xanthopsia, transient blurred vision. Cardiac Disorders Palpitation, tachycardia. Vascular Disorders Dose-related orthostatic effects, necrotizing angiitis (vasculitis, cutaneous vasculitis).

Respiratory, Thoracic and Mediastinal Disorders Nasal congestion. Gastrointestinal Disorders Dyspepsia, abdominal pain, gastric irritation, cramping, nausea, vomiting, pancreatitis, sialoadenitis. Hepato-Biliary Disorders Jaundice (intrahepatic cholestatic jaundice).

Skin and Subcutaneous Tissue Disorders Rash, pruritus, purpura, toxic epidermal necrolysis, urticaria, photosensitivity, cutaneous lupus erythematosus. Musculoskeletal and Connective Tissue Disorders Muscle cramps, muscle spasm. Renal and Urinary Disorders Glycosuria, renal dysfunction, interstitial nephritis, renal failure.

Reproductive System and Breast Disorders Erectile dysfunction/impotence. General Disorders and Administration Site Conditions Chest pain, malaise, weakness. Investigations Liver function abnormalities.

Cough Persistent dry cough has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of losartan on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy. Patients who had typical ACE-inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to losartan 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg hydrochlorothiazide (n=135).

The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below. Table 1: Study 1 Demographics = (89% Caucasian, 64% female) HCTZ Losartan Lisinopril Cough 25 % 17 % 69 % Study 2 Demographics = (90% Caucasian, 51% female) Placebo Losartan Lisinopril Cough 35 % 29% 62 % These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Agents increasing serum potassium: Risk of hyperkalemia. ( 7.1 ) Lithium: Risk of lithium toxicity. ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects.

( 7.3 ) Dual inhibition of the renin-angiotensin system: increased risk of renal impairment, hypotension, syncope, and hyperkalemia. ( 7.4 ) Antidiabetic drugs: dosage adjustment of antidiabetic may be required. ( 7.5 ) Cholestyramine and colestipol: Reduced absorption of thiazides.

( 7.5 )

7.1Agents Increasing Serum Potassium Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

7.2Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of angiotensin II receptor antagonists or thiazide diuretics. Monitor lithium levels in patients receiving losartan potassium and hydrochlorothiazide tablets and lithium.

7.3Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors Losartan Potassium In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including losartan) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving losartan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including losartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. Hydrochlorothiazide The administration of a non-steroidal anti-inflammatory agent including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when losartan potassium and hydrochlorothiazide tablets and non-steroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.

In patients receiving diuretic therapy, coadministration of NSAIDs with angiotensin receptor blockers, including losartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving hydrochlorothiazide, losartan, and NSAID therapy.

7.4Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years.

Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end-stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. Closely monitor blood pressure, renal function, and electrolytes in patients on losartan potassium and hydrochlorothiazide tablets and other agents that affect the RAS. Do not coadminister aliskiren with losartan potassium and hydrochlorothiazide tablets in patients with diabetes.

Avoid use of aliskiren with losartan potassium and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 mL/…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Losartan potassium and hydrochlorothiazide tablet is not recommended for initial therapy, because the recommended starting dose is not available. ( 8.7 )

8.1Pregnancy Risk Summary Losartan potassium and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible (see Clinical Considerations) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.

Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Losartan: Use of drugs that act on the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.

Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue losartan potassium and hydrochlorothiazide tablets, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of gestation.

Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe neonates with histories of in utero exposure to losartan potassium and hydrochlorothiazide tablets for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to losartan potassium and hydrochlorothiazide tablets, if oliguria or hypotension occurs, support blood pressure and renal perfusion.

Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Hydrochlorothiazide: Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion.

It accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not alter the course of pre-eclampsia, these drugs should not be used to treat hypertension in pregnant women.

🤰 Pregnancy ~3 min read ▾

The use of hydrochlorothiazide for other indications in pregnancy should be avoided. Data Animal Data There was no evidence of teratogenicity in rats or rabbits treated with a maximum losartan potassium dose of 10 mg/kg/day in combination with 2.5 mg/kg/day of hydrochlorothiazide. At these dosages, respective exposures (AUCs) of losartan, its active metabolite, and hydrochlorothiazide in rabbits were approximately 5, 1.5, and 1.0…

🧒 Pediatric Use 66 words ▾

8.4Pediatric Use Safety and effectiveness of losartan potassium and hydrochlorothiazide tablets in pediatric patients have not been established. Neonates with a history of in utero exposure to losartan potassium and hydrochlorothiazide tablets: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.

🧓 Geriatric Use 112 words ▾

8.5Geriatric Use In a controlled clinical study for the reduction in the combined risk of cardiovascular death, stroke and myocardial infarction in hypertensive patients with left ventricular hypertrophy, 2857 patients (62%) were 65 years and over, while 808 patients (18%) were 75 years and over. In an effort to control blood pressure in this study, patients were coadministered losartan and hydrochlorothiazide 74% of the total time they were on study drug. No overall differences in effectiveness were observed between these patients and younger patients.

Adverse events were somewhat more frequent in the elderly compared to non-elderly patients for both the losartan-hydrochlorothiazide and the control groups [see CLINICAL PHARMACOLOGY ( 12.3 )].

🆘 Overdosage 149 words ▾

10 OVERDOSAGE Losartan Potassium Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m 2 basis. Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.

If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its active metabolite can be removed by hemodialysis. Hydrochlorothiazide The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Losartan Potassium Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)], is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland).

There is also an AT 2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. Neither losartan nor its principal active metabolite exhibits any partial agonist activity at the AT 1 receptor, and both have much greater affinity (about 1000-fold) for the AT 1 receptor than for the AT 2 receptor. In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT 1 receptor.

The active metabolite is 10 to 40 times more potent by weight than losartan and appears to be a reversible, non-competitive inhibitor of the AT 1 receptor. Neither losartan nor its active metabolite inhibits ACE (kininase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin), nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Hydrochlorothiazide Hydrochlorothiazide is a thiazide diuretic.

Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.

The mechanism of the antihypertensive effect of thiazides is unknown.

12.2Pharmacodynamics Losartan Potassium Losartan inhibits the pressor effect of angiotensin II (as well as angiotensin I) infusions. A dose of 100 mg inhibits the pressor effect by about 85% at peak with 25 to 40% inhibition persisting for 24 hours. Removal of the negative feedback of angiotensin II causes a doubling to tripling in plasma renin activity and consequent rise in angiotensin II plasma concentration in hypertensive patients.

Losartan does not affect the response to bradykinin, whereas ACE inhibitors increase the response to bradykinin. Aldosterone plasma concentrations fall following losartan administration. In spite of the effect of losartan on aldosterone secretion, very little effect on serum potassium was observed.

The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3 to 6 weeks. In long-term follow-up studies (without placebo control) the effect of losartan appeared to be maintained for up to a year. There is no apparent rebound effect after abrupt withdrawal of losartan.

There was essentially no change in average heart rate in losartan-treated patients in controlled trials. Hydrochlorothiazide After oral administration of hydrochlorothiazide, diuresis begins within 2 hours, peaks in about 4 hours, and lasts about 6 to 12 hours. Drug Interactions Hydrochlorothiazide: Alcohol, Barbiturates, or Narcotics Potentiation of orthostatic hypotension may occur.

Other Antihypertensive Drugs Additive effect or potentiation. Skeletal Muscle Relaxants, Nondepolarizing (e.g., Tubocurarine) Possible increased responsiveness to the muscle relaxant. Corticosteroids, ACTH, or Glycyrrhizin (Found in Liquorice) Intensified electr…

🧬 Mechanism of Action ~1 min read ▾

The mechanism of the antihypertensive effect of thiazides is unknown.

📦 How Supplied / Storage and Handling 89 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Losartan potassium and hydrochlorothiazide tablet USP is supplied as a film-coated tablet. Losartan/ Hydrochlorothiazide Color Shape Engraving NDC 68180-xxx-xx One side Other side Bottle/30 Bottle/90 50 mg/12.5 mg Yellow Capsule shaped biconvex LU M41 215-06 215-09 100 mg/12.5 mg White Oval shaped biconvex LU M42 216-06 216-09 100 mg/25 mg Yellow Tear drop shaped biconvex LU M43 217-06 217-09 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep container tightly closed. Protect from light.

📋 Description ~2 min read ▾

11 DESCRIPTION Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p- ( o -1 H -tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22 H 22 ClKN 6 O, and its structural formula is: Image Losartan potassium is a white to off-white amorphous powder with a molecular weight of 461.01.

It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.

Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Image Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide.

Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/ 12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/ 25 mg also contain iron oxide yellow. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/ 25 mg contains 8.48 mg (0.216 mEq) of potassium. image image

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy Advise female patients of childbearing age about the consequences of exposure to losartan potassium and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with women planning to become pregnant.

Tell patients to report pregnancies to their physicians as soon as possible [see WARNINGS AND PRECAUTIONS ( 5.1 ) and USE IN SPECIFIC POPULATIONS ( 8.1 )]. Symptomatic Hypotension Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider. Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure.

If syncope occurs advise patients to contact their healthcare provider [see WARNINGS AND PRECAUTIONS ( 5.2 )]. Potassium Supplements Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see DRUG INTERACTIONS ( 7.1 )]. Acute Myopia and Secondary Angle-closure Glaucoma Advise patients to discontinue losartan potassium and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see WARNINGS AND PRECAUTIONS ( 5.6 )].

Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc.

Naples, FL 34108 United States MADE IN INDIA Revised: July 2026 Image

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

systemic lupus erythematosus: A long-term autoimmune disease in which the immune system attacks the body's own tissues, affecting joints, skin, kidneys, and other organs.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

acute kidney injury: A sudden drop in kidney function over hours or days, which is often reversible if the cause is treated.

additive effect: When two medicines that do the same thing are taken together and their effects add up to a larger combined effect.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

anuria: Producing little or no urine, which can be a sign of severe kidney problems.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysgeusia: A changed or unpleasant sense of taste, such as a metallic taste.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

end-stage renal disease: The most advanced, permanent stage of kidney failure, usually needing dialysis or a kidney transplant.

endpoint: A specific outcome, such as a symptom or lab value, that a study measures to judge whether a treatment works.

erectile dysfunction: Trouble getting or keeping an erection.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

glycosuria: Sugar (glucose) in the urine, which often happens when blood sugar is high.

gout: A type of arthritis with sudden, painful, swollen joints caused by uric acid crystals.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

intrauterine growth restriction: When a baby grows more slowly than expected in the womb and is smaller than normal at birth.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

monotherapy: Treatment using a single medicine by itself.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

oliguria: Producing much less urine than normal, which is often a sign the kidneys are under stress.

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

partial agonist: A substance that switches on a body target only part way, giving a weaker effect than a full activator would.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

rebound: The return of symptoms, sometimes worse than before, after a medicine that was controlling them is stopped.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 68180-0216-01 · Lupin 68180-0222-01 · Lupin →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Losartan Potassium and Hydrochlorothiazide 25 mg; 100 mg Tablet, 30-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

💊 Medicaid utilization by pack size

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

📄 Full prescribing information FDA SPL

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups

💊 Related drugs in this class