Losartan potassium and hydrochlorothiazide

What Losartan potassium and hydrochlorothiazide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Hypertension Losartan potassium and hydrochlorothiazide tablets are 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. …

— FDA label: Losartan Potassium and Hydrochlorothiazide, Direct_Rx, effective January 17, 2025. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, film coated, oral), Losartan Potassium and Hydrochlorothiazide, Direct_Rx; it covers 5 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 75 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY. Read it on the full label →

68 of 75 FDA labels for this medicine have a boxed warning.

Losartan potassium and hydrochlorothiazide boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

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)].

— FDA label: Losartan Potassium and Hydrochlorothiazide, Direct_Rx, effective January 17, 2025. Read the full label on DailyMed →

Losartan potassium and hydrochlorothiazide side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Clinical 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.

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Losartan potassium and 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 and 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 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, pharyngitis, sinus disorder, respiratory distress (including pneumonitis and pulmonary edema). Gastrointestinal disorders: Dyspepsia, abdominal pain, gastric irritation, cramping, diarrhea, constipation, 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, myalgia, arthralgia. 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, edema/swelling, malaise, fever, 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.

— FDA label: Losartan Potassium and Hydrochlorothiazide, Direct_Rx, effective January 17, 2025. This is part of the section. Read the full label on DailyMed →

Losartan potassium and hydrochlorothiazide drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Agents Increasing Serum Potassium Coadministration of losartan with other drugs that raise serum potassium may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of angiotensin II receptor antagonists or thiazide diuretics.

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Monitor lithium levels in patients receiving losartan potassium and hydrochlorothiazide and lithium. 7.3 Non-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 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. 7.4 Dual 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.

— FDA label: Losartan Potassium and Hydrochlorothiazide, Direct_Rx, effective January 17, 2025. This is part of the section. Read the full label on DailyMed →

Losartan potassium and hydrochlorothiazide dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Hypertension The usual starting dose of losartan potassium and hydrochlorothiazide tablets is 50 mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100 mg/25 mg (losartan 100 mg/hydrochlorothiazide 25 mg) once daily as needed to control blood pressure [see Clinical Studies (14.2)].

Read more of this section

Initiate a patient whose blood pressure is not adequately controlled with losartan 50 mg monotherapy with losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg 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 50 mg/12.5 mg once daily or one tablet of losartan potassium and hydrochlorothiazide 100 mg/25 mg once daily. Initiate a patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy with losartan potassium and hydrochlorothiazide tablets 100 mg/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 50 mg/12.5 mg once daily or one tablet of losartan potassium and hydrochlorothiazide 100 mg/25 mg 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 tablets 50 mg/12.5 mg once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. Evaluate the clinical response to losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg and, if blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of losartan potassium and hydrochlorothiazide 50 mg/12.5 mg once daily or one tablet of losartan potassium and hydrochlorothiazide 100 mg/25 mg once daily. 2.2 Hypertensive 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 tablets 50 mg/12.5 mg. If additional blood pressure reduction is needed, increase the dose to losartan potassium and hydrochlorothiazide tablets 100 mg/12.5 mg, followed by losartan potassium and hydrochlorothiazide tablets 100 mg/25 mg. For further blood pressure reduction add other antihypertensives [see Clinical Studies (14)].

— FDA label: Losartan Potassium and Hydrochlorothiazide, Direct_Rx, effective January 17, 2025. Read the full label on DailyMed →

When Losartan potassium and hydrochlorothiazide should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Losartan potassium and hydrochlorothiazide tablets are contraindicated:

• In patients who are hypersensitive to any component of this product.
• In patients with anuria
• For coadministration with aliskiren in patients with diabetes

— FDA label: Losartan Potassium and Hydrochlorothiazide, Direct_Rx, effective January 17, 2025. Read the full label on DailyMed →

Losartan potassium and hydrochlorothiazide overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

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/m2 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.

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If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its active metabolite can be removed by hemodialysis. Hydrochlorothiazide The oral LD50 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.

— FDA label: Losartan Potassium and Hydrochlorothiazide, Direct_Rx, effective January 17, 2025. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines with one of these active ingredients

• Losartan potassiumLosortan Potassium, Cozaar · 207 products
• HydrochlorothiazideInzirqo · 171 products
• Valsartan and hydrochlorothiazideDiovan Hct · 104 products
• Lisinopril and hydrochlorothiazideZestoretic · 95 products
• Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 81 products
• Triamterene and hydrochlorothiazide69 products
• Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideTribenzor · 43 products
• Bisoprolol fumarate and hydrochlorothiazide42 products
• Irbesartan and hydrochlorothiazideAvalide · 31 products
• Amlodipine besylate valsartan hydrochlorothiazideExforge Hct · 30 products
• Telmisartan and hydrochlorothiazideMicardis Hct · 27 products
• Benazepril hydrochloride and hydrochlorothiazideLotensin Hct · 21 products
• Candesartan cilexetil and hydrochlorothiazideAtacand Hct · 16 products
• Metoprolol tartrate and hydrochlorothiazide14 products
• Quinapril HCL and hydrochlorothiazide12 products
• Spironolactone and hydrochlorothiazide12 products
• Enalapril maleate and hydrochlorothiazideVaseretic · 5 products
• Captopril and hydrochlorothiazide4 products
• Fosinopril sodium and hydrochlorothiazide4 products
• Amiloride hydrochloride and hydrochlorothiazide1 product

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Bryant Ranch Prepack16 products
• A-S Medication Solutions15 products
• Proficient Rx LP9 products
• Direct_Rx8 products
• DirectRx4 products
• Remedyrepack Inc.4 products
• Organon LLC3 products
• Alembic Pharmaceuticals Inc.3 products
• Lupin Pharmaceuticals, Inc.3 products
• Teva Pharmaceuticals USA, Inc.3 products
• Macleods Pharmaceuticals Limited3 products
• AvKARE3 products
• Aurobindo Pharma Limited3 products
• NorthStar Rx LLC3 products
• Unichem Pharmaceuticals (USA), Inc.3 products
• Camber Pharmaceuticals, Inc.3 products
• Preferred Pharmaceuticals Inc.3 products
• Solco Healthcare US, LLC3 products
• Alembic Pharmaceuticals Limited3 products
• Granules Pharmaceuticals Inc.3 products
• Jubilant Cadista Pharmaceuticals Inc.3 products
• PD-Rx Pharmaceuticals, Inc.2 products
• NuCare Pharmaceuticals, Inc.2 products
• QPharma, Inc.2 products
• Coupler LLC1 product
• Aphena Pharma Solutions - Tennessee, LLC1 product
• St. Mary's Medical Park Pharmacy1 product
• Quality Care Products, LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (10)

• ANDA077157Teva Pharms · April 6, 2010
• ANDA078245Lupin Ltd · May 21, 2010
• ANDA091629Aurobindo Pharma · October 6, 2010
• ANDA091617Alembic Pharms Ltd · February 17, 2012
• ANDA202289Macleods Pharms Ltd · August 9, 2012
• ANDA201845Jubilant Cadista · September 18, 2012
• ANDA204832Unichem · July 21, 2017
• ANDA204901Prinston Inc · November 6, 2017
• ANDA218015Granules · September 29, 2023
• ANDA219869Hetero Labs Ltd V · May 27, 2026

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. May 7, 2024 · Class II · Ongoing · D-0498-2024

   Presence of foreign substance: plastic-like substance.

   Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Hi — MACLEODS PHARMA USA, INC

2. June 10, 2022 · Class II · Terminated · D-1164-2022

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 — Macleods Pharma Usa Inc

3. May 11, 2022 · Class II · Terminated · D-0894-2022

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

   Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 — Direct Rx

4. May 11, 2022 · Class II · Terminated · D-0895-2022

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

   Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 — Direct Rx

5. May 11, 2022 · Class II · Terminated · D-0893-2022

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

   Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 — Direct Rx

6. May 5, 2022 · Class II · Terminated · D-0971-2022

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90 — Direct Rx

7. April 15, 2022 · Class II · Terminated · D-0835-2022

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods P — Macleods Pharma Usa Inc

8. April 15, 2022 · Class II · Terminated · D-0837-2022

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods — Macleods Pharma Usa Inc

9. April 15, 2022 · Class II · Terminated · D-0836-2022

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Ph — Macleods Pharma Usa Inc

10. March 31, 2022 · Class II · Terminated · D-0841-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: L — Lupin Pharmaceuticals Inc.

11. March 31, 2022 · Class II · Terminated · D-0843-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: — Lupin Pharmaceuticals Inc.

12. March 31, 2022 · Class II · Terminated · D-0842-2022

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lu — Lupin Pharmaceuticals Inc.

13. June 20, 2019 · Class II · Terminated · D-1460-2019

    CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Prade — Macleods Pharma Usa Inc

14. June 20, 2019 · Class II · Terminated · D-1459-2019

    CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Prades — Macleods Pharma Usa Inc

15. June 20, 2019 · Class II · Terminated · D-1461-2019

    CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

    Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Prad — Macleods Pharma Usa Inc

16. July 11, 2014 · Class II · Terminated · D-1500-2014

    Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

    Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90 — Jubilant Cadista Pharmaceuticals Inc.

Official identifiers

Next steps

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• StrokeCondition named on the label: hospitals that treat it
• Bryant Ranch PrepackMaker or distributor
• A-S Medication SolutionsMaker or distributor
• Proficient Rx LPMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Losartan Potassium and Hydrochlorothiazide, Direct_Rx, effective January 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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