Skip to main content

Prescription medicine

Amoxicillin and clarithromycin and lansoprazole First approved as Prevpac (Copackaged)

Amoxicillin and clarithromycin and lansoprazole (Prevpac (Copackaged)) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $6.04 per unit (Lansoprazol-amoxicil-clarithro) in the October 7, 2026 NADAC survey.

  • Generic listed

Check it at the source: the amoxicillin and clarithromycin and lansoprazole FDA label on DailyMed (effective February 19, 2025, Rising Pharma Holdings, Inc.); the NDA 50757 record on Drugs@FDA; every amoxicillin and clarithromycin and lansoprazole label on DailyMed.

Highlights of the record

FDA label of February 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

H.

Forms and strengths

Kit.

On the market

Earliest approval on file
December 2, 1997 Prevpac (Copackaged), Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
3 first August 30, 2013; 2 with a marketed status in Drugs@FDA
Labelers listed (NDC)
1 of which 1 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
$6.04 per unit Lansoprazol-amoxicil-clarithro
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
8 through July 30, 2026

What is amoxicillin and clarithromycin and lansoprazole used for?

From the label: indications and usage

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence The components in lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see CLINICAL STUDIES and DOSAGE AND ADMINISTRATION ). […]

Conditions named in the indications of amoxicillin and clarithromycin and lansoprazole's FDA labels, with every medicine labeled for each:

From other amoxicillin and clarithromycin and lansoprazole labels

Acid reflux and ulcers: INDICATIONS AND USAGE H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence The components in lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets are indicated for the treatment of …

Source: FDA drug label (Lansoprazole, Amoxicillin, Clarithromycin), Rising Pharma Holdings, Inc., effective February 19, 2025 (SPL set 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00), via openFDA; the full label on DailyMed

Is there a generic for amoxicillin and clarithromycin and lansoprazole (Prevpac (Copackaged))?

The FDA approved the first generic amoxicillin and clarithromycin and lansoprazole on August 30, 2013. 3 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists amoxicillin and clarithromycin and lansoprazole from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

  • 1997 earliest approval on file
  • 2013 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for amoxicillin and clarithromycin and lansoprazole (Prevpac (Copackaged))?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.04 per unit (Lansoprazol-amoxicil-clarithro), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Lansoprazol-amoxicil-clarithro (generic)
$6.12
$4.50
April 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Lansoprazol-amoxicil-clarithroGeneric$6.04 per unitn/a-0.6%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the amoxicillin and clarithromycin and lansoprazole label say about other medicines?

The amoxicillin and clarithromycin and lansoprazole label names 73 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Alprazolamdrug interactionsAlprazolam Triazolam Triazolam, Alprazolam: Caution and appropriate dose adjustments should be considered when triazolam or alprazolam is coadministered with clarithromycin.
Amiodaronedrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). … Recommendation Comments Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing reports of torsades de pointes occurring …
Amlodipinedrug interactionsAmlodipine Diltiazem Amlodipine, Diltiazem: (see WARNINGS ).
Atazanavirdrug interactionsAntiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … Intervention: Rilpivirine-containing products: Concomitant use with lansoprazole is contraindicated (see). See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. …
Atorvastatindrug interactionsHMG-CoA Reductase Inhibitors: Lovastatin Simvastatin Contraindicated Lovastatin, Simvastatin, Atorvastatin, Pravastatin, Fluvastatin: (see CONTRAINDICATIONS , WARNINGS ).
Bromocriptinedrug interactionsOther Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisolone Vinblastine Phenobarbital St. John's Wort Use With Caution There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with alfentanil, methylprednisolone, cilostazol, bromocriptine, vinblastine …
Carbamazepinedrug interactionsCarbamazepine; Use With Caution; Carbamazepine: Concomitant administration of single doses of clarithromycin and carbamazepine has been shown to result in increased plasma concentrations of carbamazepine. Blood level monitoring of carbamazepine may be considered. …
Chloramphenicoldrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). … result in increased and prolonged blood levels of amoxicillin. Antibiotics Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with bactericidal effects of penicillin. …
Cilostazoldrug interactionsOther Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisolone Vinblastine Phenobarbital St. John's Wort Use With Caution There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with alfentanil, methylprednisolone, cilostazol, bromocriptine, vinblastine …
ColchicinecontraindicationsConcomitant administration of clarithromycin and colchicine is contraindicated in patients with renal or hepatic impairment.
Cyclosporinedrug interactionsImmunosuppressants: Cyclosporine Use With Caution Cyclosporine: There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with cyclosporine.
Dasatinibdrug interactionsClinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid …
Digoxindrug interactionsClinical Impact: Potential for increased exposure of digoxin. Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin.
DihydroergotaminecontraindicationsConcomitant administration of clarithromycin, a component of lansoprazole delayed-release capsules, amoxicillin capsules, and clarithromycin tablets, and any of the following drugs is contraindicated: cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine (see PRECAUTIONS, Drug Interactions ).

Every other medicine the amoxicillin and clarithromycin and lansoprazole label names

Medicine namedSectionWhat the label says
Diltiazemdrug interactionsAmlodipine Diltiazem Amlodipine, Diltiazem: (see WARNINGS ).
Disopyramidedrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). … Affected by Clarithromycin tablets Recommendation Comments Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing …
Dofetilidedrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). … Clarithromycin tablets Recommendation Comments Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing reports of …
Efavirenzdrug interactionsEfavirenz Nevirapine Rifampicin Rifabutin Rifapentine; Use With Caution; Inducers of CYP3A enzymes, such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine will increase the metabolism …
Ergotaminecontraindications… is contraindicated: cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine (see PRECAUTIONS, Drug Interactions ).
Erlotinibdrug interactionsClinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid …
ErythromycincontraindicationsClarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibiotics.
Etravirinedrug interactionsEtravirine Etravirine: Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, 14-OH-clarithromycin, were increased.
Fluconazoledrug interactionsFluconazole No Dose Adjustment Fluconazole: No dosage adjustment of clarithromycin is necessary when coadministered with fluconazole.
Fluvastatindrug interactionsHMG-CoA Reductase Inhibitors: Lovastatin Simvastatin Contraindicated Lovastatin, Simvastatin, Atorvastatin, Pravastatin, Fluvastatin: (see CONTRAINDICATIONS , WARNINGS ).
Itraconazoledrug interactionsClinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid …
Ketoconazoledrug interactionsClinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid …
Lorazepamdrug interactionsTemazepam Nitrazepam Lorazepam; No Dose Adjustment; Temazepam, Nitrazepam, Lorazepam: For benzodiazepines which are not metabolized by CYP3A (e.g., temazepam, nitrazepam, lorazepam), a clinically …
LovastatincontraindicationsClarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increase risk of …
LurasidonecontraindicationsClarithromycin is contraindicated with concomitant use of lurasidone due to the risk of an increase in lurasidone exposure and the potential for serious adverse reactions [(see PRECAUTIONS , Drug …
Maravirocdrug interactionsMaraviroc Maraviroc: Clarithromycin may result in increases in maraviroc exposures by inhibition of CYP3A metabolism.
Methotrexatedrug interactionsMethotrexate Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. … Intervention: A temporary withdrawal of lansoprazole may be considered in some patients receiving high-dose methotrexate.
Methylprednisolonedrug interactionsOther Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisolone Vinblastine Phenobarbital St. John's Wort Use With Caution There have been spontaneous or published reports of …
Midazolamdrug interactionsWhen oral midazolam is coadministered with clarithromycin, dose adjustments may be necessary and possible prolongation and intensity of effect should be anticipated (see WARNINGS ).
Mycophenolate mofetildrug interactionsClinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid …
Mycophenolic aciddrug interactionsClinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. … receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. …
Nateglinidedrug interactionsNateglinide Pioglitazone Repaglinide Rosiglitazone Use With Caution Nateglinide, Pioglitazone, Repaglinide, Rosiglitazone: (see WARNINGS , ADVERSE REACTIONS ).
Nelfinavirdrug interactionsAntiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with lansoprazole. See prescribing information for nelfinavir. …
Nevirapinedrug interactionsEfavirenz Nevirapine Rifampicin Rifabutin Rifapentine; Use With Caution; Inducers of CYP3A enzymes, such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine will increase the metabolism …
Nifedipinedrug interactionsHypotension and peripheral edema were observed when clarithromycin was taken concomitantly with nifedipine (see WARNINGS ).
Nilotinibdrug interactionsClinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid …
Omeprazoledrug interactionsOmeprazole; No Dose Adjustment; Omeprazole: The mean 24 hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when coadministered with clarithromycin as a result of increased …
Phenobarbitaldrug interactionsOther Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisolone Vinblastine Phenobarbital St. John's Wort Use With Caution There have been spontaneous or published reports of …
Phenytoindrug interactionsHexobarbital Phenytoin Valproate; Use With Caution; There have been postmarketing reports of interactions of clarithromycin with drugs not thought to be metabolized by CYP3A, including hexobarbital …
Pimozidecontraindications… tablets, and any of the following drugs is contraindicated: cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine (see PRECAUTIONS, Drug Interactions ).
Pioglitazonedrug interactionsNateglinide Pioglitazone Repaglinide Rosiglitazone Use With Caution Nateglinide, Pioglitazone, Repaglinide, Rosiglitazone: (see WARNINGS , ADVERSE REACTIONS ).
Pravastatindrug interactionsHMG-CoA Reductase Inhibitors: Lovastatin Simvastatin Contraindicated Lovastatin, Simvastatin, Atorvastatin, Pravastatin, Fluvastatin: (see CONTRAINDICATIONS , WARNINGS ).
Probeneciddrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). Intervention: Take lansoprazole delayed-release capsules at least 30 minutes prior to sucralfate (see CLINICAL PHARMACOLOGY ). Amoxicillin Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. …
Procainamidedrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). … Comments Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing reports of torsades de pointes occurring with concurrent …
Progesteronedrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). … lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. Clinically Significant Drug Interactions with Clarithromycin Tablets Drugs That Are Affected By Clarithromycin …
Quetiapinedrug interactionsQuetiapine Quetiapine: Quetiapine is a substrate for CYP3A4, which is inhibited by clarithromycin.
Quinidinedrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). … Clarithromycin tablets Recommendation Comments Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing reports of …
Repaglinidedrug interactionsNateglinide Pioglitazone Repaglinide Rosiglitazone Use With Caution Nateglinide, Pioglitazone, Repaglinide, Rosiglitazone: (see WARNINGS , ADVERSE REACTIONS ).
Rifabutindrug interactionsRifabutin; Use With Caution; Rifabutin: Concomitant administration of rifabutin and clarithromycin resulted in an increase in rifabutin, and decrease in clarithromycin serum levels together with an …
Rifampindrug interactionsClinical Impact: Decreased exposure of lansoprazole when used concomitantly with strong inducers (…). Intervention: St John's Wort, rifampin: Avoid concomitant use with lansoprazole. Ritonavir-containing products: See prescribing information. CYP2C19 or CYP3A4 Inhibitors
Rifapentinedrug interactionsEfavirenz Nevirapine Rifampicin Rifabutin Rifapentine; Use With Caution; Inducers of CYP3A enzymes, such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine will increase the metabolism …
Rilpivirinedrug interactionsAntiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … Intervention: Rilpivirine-containing products: Concomitant use with lansoprazole is contraindicated (see). See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. …
Ritonavirdrug interactionsRitonavir Etravirine; Ritonavir, Etravirine: (see Ritonavir and Etravirine under "Drugs That Affect Clarithromycin Tablets" in the table below).
Sildenafildrug interactionsPhosphodiesterase Inhibitors: Sildenafil Tadalafil Vardenafil Use With Caution Sildenafil, Tadalafil, Vardenafil:
Simvastatincontraindications… (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increase risk of myopathy, including rhabdomyolysis (see WARNINGS ).
Sotaloldrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). … Recommendation Comments Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing reports of torsades de pointes occurring …
Sucralfatedrug interactionsClinical Impact: Decreased and delayed absorption of lansoprazole (…). Intervention: Take lansoprazole delayed-release capsules at least 30 minutes prior to sucralfate (see CLINICAL PHARMACOLOGY ). Amoxicillin Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. …
Tacrolimusdrug interactionsTacrolimus Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. Intervention: Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus.
Tadalafildrug interactionsPhosphodiesterase Inhibitors: Sildenafil Tadalafil Vardenafil Use With Caution Sildenafil, Tadalafil, Vardenafil:
Temazepamdrug interactionsTemazepam Nitrazepam Lorazepam; No Dose Adjustment; Temazepam, Nitrazepam, Lorazepam: For benzodiazepines which are not metabolized by CYP3A (e.g., temazepam, nitrazepam, lorazepam), a clinically …
Theophyllinedrug interactionsClinical Impact: Increased clearance of theophylline (…). Intervention: Individual patients may require additional titration of their theophylline dosage when lansoprazole is started or stopped to ensure clinically effective blood concentrations.
Tolterodinedrug interactionsIn this population subset, inhibition of CYP3A results in significantly higher serum concentrations of tolterodine.
Triazolamdrug interactionsAlprazolam Triazolam Triazolam, Alprazolam: Caution and appropriate dose adjustments should be considered when triazolam or alprazolam is coadministered with clarithromycin.
Vardenafildrug interactionsPhosphodiesterase Inhibitors: Sildenafil Tadalafil Vardenafil Use With Caution Sildenafil, Tadalafil, Vardenafil:
Verapamildrug interactionsCalcium Channel Blockers: Verapamil Use With Caution Verapamil: Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil (see WARNINGS ).
Vinblastinedrug interactionsOther Drugs Metabolized by CYP3A: Alfentanil Bromocriptine Cilostazol Methylprednisolone Vinblastine Phenobarbital St. John's Wort Use With Caution There have been spontaneous or published reports of …
Voriconazoledrug interactionsClinical Impact: Increased exposure of lansoprazole is expected when used concomitantly with strong inhibitors (…). Intervention: Voriconazole: See prescribing information.
Warfarindrug interactionsClinical Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.
Zidovudinedrug interactionsZidovudine; Zidovudine: Simultaneous oral administration of clarithromycin immediate-release tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine …

Check amoxicillin and clarithromycin and lansoprazole against other medicines

Source: FDA drug label (Lansoprazole, Amoxicillin, Clarithromycin), Rising Pharma Holdings, Inc., effective February 19, 2025 (SPL set 40adc1d3-7ce7-4698-aa7f-b5dbaaecec00), via openFDA; the full label on DailyMed

What do FAERS reports show for amoxicillin and clarithromycin and lansoprazole?

The FDA Adverse Event Reporting System holds 8 reports that list amoxicillin and clarithromycin and lansoprazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Altered State Of Consciousness (named in the label)1
  • Anxiety (named in the label)1
  • Cerebral Artery Embolism1
  • Cerebral Infarction (named in the label)1
  • Cerebral Thrombosis1
  • Coma1
  • Dermatitis Atopic1
  • Disturbance In Attention1

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Check an interaction
what two or more labels say about each other