Azithromycin
Azithromycin is a macrolide antibiotic used to treat mild to moderate bacterial infections of the lungs, sinuses, throat, ears, skin and genital tract, with an IV form for pneumonia and pelvic inflammatory disease and eye drops for bacterial conjunctivitis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 172 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Azithromycin (the Z-Pak) is one of the most prescribed antibiotics, used for mild to moderate bacterial infections of the chest, sinuses, throat, ears, skin and genital tract; it blocks the machinery bacteria use to make proteins, has been around since about 1995 and is available generically. Most people handle its short course well, though loose stools, nausea and stomach upset are common; it does nothing for colds or flu. The warning signs that matter are a racing or irregular heartbeat or fainting (it can disturb heart rhythm, called QT prolongation), facial swelling or a blistering rash, yellow skin or eyes, and severe diarrhea.
Clinical pearls
- The course is short because the drug lingers in your tissues, so finish every dose even if you feel better.
- On warfarin, ask for an extra clotting check (prothrombin time), because azithromycin can strengthen warfarin's blood-thinning effect.
- Before starting, mention long QT syndrome, low potassium or magnesium, or heart rhythm drugs such as amiodarone, sotalol or dofetilide.
- Severe watery diarrhea can appear even weeks after the course ends, so tell whoever sees you about the recent antibiotic.
Patient information guide A plain-language walkthrough of Azithromycin, written from its FDA label.
What Azithromycin is used for
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Azithromycin is used for several bacterial infections, depending on the product.
- Oral tablets and oral suspension (including Zithromax): acute bacterial flare-ups of chronic bronchitis in adults
- Acute bacterial sinusitis in adults
- Uncomplicated skin and skin structure infections in adults
- Urethritis and cervicitis in adults
- Genital ulcer disease in men
- Acute otitis media (ear infection) in children 6 months and older
- Community-acquired pneumonia in adults and children 6 months and older
- Pharyngitis/tonsillitis in adults and children 2 years and older
- Zithromax and azithromycin for injection (IV): community-acquired pneumonia in adults needing initial IV therapy, and pelvic inflammatory disease
- AzaSite eye drops: bacterial conjunctivitis
How Azithromycin works
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Azithromycin is a macrolide antibiotic. It binds to part of the bacterial ribosome (the cell's protein-making machinery), which blocks protein production and the assembly of the ribosome. Without those proteins, the bacteria cannot grow.
Bacteria can become resistant, often by changing that binding site. Azithromycin shows cross-resistance with erythromycin and some related antibiotics.
Azithromycin dosage
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Azithromycin comes as tablets, oral suspension, IV injection and eye drops. Tablets are taken by mouth with or without food. Treatment is usually short, from one dose to several days, depending on the infection and age.
- IV azithromycin is given by a healthcare professional and may be followed by tablets.
- AzaSite eye drops are used twice daily for two days, then once daily.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Azithromycin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Community-acquired pneumonia (mild severity); Pharyngitis/tonsillitis (second-line therapy); Skin/skin structure (uncomplicated) - adults
- 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
- Tablets and oral suspension can be taken with or without food
- Acute bacterial exacerbations of chronic bronchitis / chronic obstructive pulmonary disease (mild to moderate) - adults
- 500 mg once daily for 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
- Can be taken with or without food
- Acute bacterial sinusitis - adults
- 500 mg once daily for 3 days
- Genital ulcer disease (chancroid); Non-gonococcal urethritis and cervicitis - adults
- One single 1 gram dose
- Gonococcal urethritis and cervicitis - adults
- One single 2 gram dose
- Acute otitis media - pediatric patients (6 months of age and older)
- 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5
- Weight-based; oral suspension can be taken with or without food; safety of re-dosing after vomiting a 30 mg/kg single dose has not been established
- Acute bacterial sinusitis - pediatric patients (6 months of age and older)
- 10 mg/kg once daily for 3 days
- Weight-based; effectiveness of the 5-day or 1-day regimen has not been established
- Community-acquired pneumonia - pediatric patients (6 months of age and older)
- 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5
- Weight-based; effectiveness of the 3-day or 1-day regimen has not been established
- Pharyngitis/tonsillitis - pediatric patients (2 years of age and older)
- 12 mg/kg once daily for 5 days
- Weight-based
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended Dosage for Adult Patients ( 2.1 ) Infection Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days. Acute bacterial sinusitis 500 mg once daily for 3 days. Genital ulcer disease (chancroid) Non-gonococcal urethritis and cervicitis One single 1 gram dose. Gonococcal urethritis and cervicitis One single 2 gram dose. Recommended Dosage for Pediatric Patients ( 2.2 ) Infection Recommended Dose/Duration of Therapy Acute otitis media (6 months of age and older) 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5. Acute bacterial sinusitis (6 months of age and older) 10 mg/kg once daily for 3 days. Community-acquired pneumonia (6 months of age and older) 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. Pharyngitis/tonsillitis (2 years of age and older) 12 mg/kg once daily for 5 days. 2.1 Recommended Dosage for Adult Patients Recommended dosages and durations of therapy in adult patient populations vary by indications [see Indications and Usage (1.1) and Clinical Pharmacology (12.3) ]. Azithromycin for oral suspension can be taken with or without food. Table 1.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Azithromycin side effects
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Most side effects are mild to moderate and involve the stomach and gut.
Common side effects
- Diarrhea or loose stools
- Nausea
- Stomach pain
- Vomiting
- Indigestion or gas
- Headache
- Dizziness
- Rash (more noted in children)
When to get medical help
- Seek emergency help for swelling of the face or throat, trouble breathing, or a severe rash with blistering or peeling. These can be serious allergic or skin reactions.
- Call your doctor right away for signs of liver problems such as yellow skin or eyes, dark urine, or severe stomach pain.
- Get help for a fast, pounding or irregular heartbeat, or fainting. Azithromycin can affect heart rhythm (QT prolongation).
- Call your doctor if you have severe or watery diarrhea, during treatment or even weeks later.
- Tell your doctor if muscle weakness gets worse if you have myasthenia gravis.
- If a newborn given azithromycin has vomiting or irritability with feeding, contact a doctor.
- Report hearing loss, ringing in the ears, or changes in taste or smell.
Azithromycin warnings and precautions
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- Serious allergic and skin reactions, some fatal. Symptoms can come back after treatment stops.
- Liver injury, including hepatitis and liver failure. Stop and call right away if signs of hepatitis appear.
- QT prolongation and dangerous heart rhythms (torsades de pointes), mainly in people with heart rhythm problems, low potassium or magnesium, or on QT-prolonging drugs. Older adults may be more susceptible.
- A possible small short-term increase in cardiovascular death seen in some observational studies; cause not confirmed.
- C. difficile diarrhea, which can occur even months after treatment.
- Worsening muscle weakness in myasthenia gravis.
- Pyloric stenosis in newborns treated in the first 42 days of life.
- Not reliable for syphilis; testing is advised with urethritis or cervicitis.
Azithromycin interactions
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A few medicines need extra care with azithromycin.
- Warfarin: may strengthen its effect, so clotting tests are monitored.
- Nelfinavir: raises azithromycin levels, so watch for liver and hearing issues.
- QT-prolonging drugs (such as quinidine, procainamide, dofetilide, amiodarone, sotalol): added heart rhythm risk.
- Digoxin, colchicine, phenytoin: careful monitoring is advised.
Interactions listed in the FDA-approved label
From the Azithromycin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Nelfinavir: Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Dose adjustment of azithromycin is not recommended, but close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted.
- Warfarin (oral anticoagulants): Spontaneous postmarketing reports suggest azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although prothrombin time was not affected in the dedicated drug interaction study. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.
- Digoxin, colchicine or phenytoin: Interactions have not been reported in clinical trials with azithromycin, and no specific drug interaction studies have been performed, but interactions have been observed with other macrolide products. Careful monitoring of patients is advised until further data are developed.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. ( 7.1 ). • Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. ( 7.2 ). 7.1 Nelfinavir Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted [see Adverse Reactions ( 6 )] . 7.2 Warfarin Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. 7.3 Potential Drug-Drug Interaction with Macrolides Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin. No specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Azithromycin
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- Do not use if allergic to azithromycin, erythromycin, or any macrolide or ketolide.
- Do not use if it previously caused jaundice or liver problems.
- Tell your prescriber about heart rhythm problems, slow heartbeat, heart failure, or low potassium or magnesium.
- Tell your prescriber if you have myasthenia gravis or liver or kidney problems.
- Pregnancy: data over decades have not identified added risks for birth defects or miscarriage.
- Breastfeeding: azithromycin passes into milk. Watch the baby for diarrhea, vomiting or rash.
- Children: not established under 6 months for ear infection, sinusitis and pneumonia, or under 2 years for pharyngitis/tonsillitis.
- Older adults: may be more sensitive to heart rhythm effects.
Azithromycin overdose
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Too much azithromycin causes effects similar to usual side effects, especially nausea, diarrhea and vomiting. If an overdose happens, general symptom-relieving and supportive care is used. Contact a doctor or poison control right away.
What Azithromycin does in the body
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Azithromycin's antibacterial effect appears to relate to how much drug exposure there is compared with the amount needed to stop the bacteria, based on animal studies. In a study of healthy people also given chloroquine, azithromycin lengthened the QTc interval (a heart rhythm measurement) in a dose-related way.
How your body processes Azithromycin
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Azithromycin is absorbed after oral dosing, and food raised peak levels slightly without changing total absorption. It spreads widely into tissues such as skin, lung, tonsil and cervix. It is cleared slowly, with a half-life of about 68 hours, since it is taken up by tissues and released gradually. It is eliminated mainly through bile, mostly unchanged, and about 6% appears in urine over a week.
How to store Azithromycin
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Store dry powder below 30°C (86°F). Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Azithromycin
92 supplements and herbal products have documented interactions with Azithromycin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 71
- Minor · 13
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Azithromycin has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Azithromycin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Azithromycin — the kind of thing our pharmacy team would talk through with you at the counter.
What is azithromycin for?
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Should I take it with food?
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What side effects should I expect?
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When should I call my doctor or get help right away?
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Are there medicines or conditions I should mention?
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Is it safe in pregnancy or while breastfeeding?
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Is Azithromycin available over the counter?
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When was Azithromycin first available?
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Who makes Azithromycin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Azithromycin on HelloPharmacist
Azithromycin forms and strengths (how it comes)
Azithromycin is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Zithromax tablets and azithromycin tablets are used for bronchitis flare-ups, sinusitis, skin infections, urethritis and cervicitis, genital ulcer disease in men, pneumonia and pharyngitis/tonsillitis.
- Azithromycin tablets can be taken with or without food.
- Azithromycin tablets are taken by mouth, once daily or as a single dose depending on the infection, as prescribed.
Oral suspension
How this form is used
- Zithromax oral suspension and azithromycin for oral suspension are used for mild to moderate infections, including ear infections and pneumonia in children 6 months and older.
- Azithromycin oral suspension is taken by mouth, and dosing and length of treatment vary by infection and by patient age.
- Azithromycin oral suspension taken with food raised peak blood levels in a study without changing the total amount absorbed.
Injection
How this form is used
- Zithromax for injection and azithromycin for injection are used for community-acquired pneumonia in adults who need initial IV therapy.
- Zithromax for injection and azithromycin for injection are used for pelvic inflammatory disease.
- Zithromax for injection is given by vein once daily.
- Zithromax for injection for pneumonia is given for at least two days, then followed by azithromycin tablets to finish the course, at the physician's discretion.
Eye drops
How this form is used
- AzaSite is used to treat bacterial conjunctivitis caused by susceptible bacteria.
- AzaSite is dropped into the affected eye(s), twice daily for the first two days and then once daily for the next five days.
- AzaSite: wash your hands first.
- AzaSite: turn the closed bottle upside down and shake once before each use.
Azithromycin on the U.S. market: products, makers and brands
How Azithromycin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
53 companies list 203 Azithromycin product records with the FDA, mostly as tablet, oral suspension, injection; the earliest marketing or approval year on record is 1991. Brand names on the directory include Zithromax, Zithromax Single Dose Packets, Zithromax Tri-Paks and 3 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Azithromycin is used (Medicaid data)
A general measure of how commonly Azithromycin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Azithromycin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Azithromycin prescribed? Of the 1,601 medications we measure, Azithromycin ranks #40 by Medicaid prescriptions — more than 98% of them.
Utilization by Azithromycin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
azithromycin 40 MG/ML Oral Suspension Most dispensed
Summed across the 18 of 77 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 141963
azithromycin 250 MG Oral Tablet
Summed across the 16 of 176 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308460
azithromycin 500 MG Oral Tablet
Summed across the 13 of 146 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 248656
azithromycin 20 MG/ML Oral Suspension
Summed across the 5 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308459
azithromycin 500 MG Injection
Summed across the 10 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1668238
azithromycin 600 MG Oral Tablet
Summed across the 4 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 204844
azithromycin 10 MG/ML Ophthalmic Solution
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 706868
Other Azithromycin products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 28 of 211 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Azithromycin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 95 of 684 listed Azithromycin NDCs with Medicaid activity.
Compare Azithromycin products
A representative set of FDA-listed product records for Azithromycin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 10 mg/mL | Ophthalmic | Thea Pharma Inc. | NDA | View NDC → |
| 💊Injection | ||||
| 500 mg/5 mL | Intravenous | Athenex Pharmaceutical Division, LLC. × 2 listings | ANDA | View NDC → |
| 500 mg | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 500 mg/5 mL | Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 500 mg/10 mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 500 mg/5 mL | Intravenous | Pfizer Laboratories Div Pfizer Inc × 2 listings | NDA | View NDC → |
| 200 mg/5 mL | Parenteral | Preferred Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg/5 mL | Parenteral | Proficient Rx LP | ANDA | View NDC → |
| 500 mg/5 mL | Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 500 mg/5 mL | Intravenous | Slate Run Pharmaceuticals | ANDA | View NDC → |
| 500 mg/5 mL | Intravenous | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 500 mg/10 mL | Intravenous | Sun Pharmaceutical Industries Limited | ANDA | View NDC → |
| 💊Oral suspension | ||||
| 100 mg/5 mL | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 200 mg/5 mL | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 100 mg/5 mL | Oral | AiPing Pharmaceutical, Inc. | ANDA | View NDC → |
| 200 mg/5 mL | Oral | AiPing Pharmaceutical, Inc. | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 200 mg/5 mL | Oral | DirectRx | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Epic Pharma, LLC × 3 listings | ANDA | View NDC → |
| 100 mg/5 mL | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 200 mg/5 mL | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg/5 mL | Oral | NuCare Pharmaceuticals,Inc. × 3 listings | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Pfizer Laboratories Div Pfizer Inc × 3 listings | NDA | View NDC → |
| 100 mg/5 mL | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Proficient Rx LP × 3 listings | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Puracap Laboratories Llc Dba Blu Pharmaceuticals × 3 listings | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Redpharm Drug | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Slate Run Pharmaceuticals, LLC | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Slate Run Pharmaceuticals, LLC × 3 listings | ANDA | View NDC → |
| 100 mg/5 mL | Oral | State Health Services, Texas Department Of | ANDA | View NDC → |
| 200 mg/5 mL | Oral | State Health Services, Texas Department Of | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Zhejiang Poly Pharm. Co., Ltd. | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Zhejiang Poly Pharm. Co., Ltd. × 3 listings | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Zydus Lifesciences Limited × 3 listings | ANDA | View NDC → |
| 100 mg/5 mL | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 200 mg/5 mL | Oral | Zydus Pharmaceuticals USA Inc. × 3 listings | ANDA | View NDC → |
| 💊Tablet | ||||
| 250 mg | Oral | A-S Medication Solutions × 7 listings | ANDA | View NDC → |
| 500 mg | Oral | A-S Medication Solutions × 8 listings | ANDA | View NDC → |
| 250 mg | Oral | Advanced Rx of Tennessee, LLC | ANDA | View NDC → |
| 500 mg | Oral | Advanced Rx of Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 250 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 250 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 500 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 600 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 250 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 500 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 600 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 250 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 500 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 600 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 250 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 600 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 250 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 500 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
Showing 102 of 203 products — FDA National Drug Code Directory. See every product, package size and price: browse all 203 Azithromycin NDCs →
Azithromycin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Azithromycin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Azithromycin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Azithromycin FDA approval history
How Azithromycin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Azithromycin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Azithromycin recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10 Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that i… FDA record D-0997-2022 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 18631 6 dose forms · 10 strengths
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Dose form (SCDF) Injection RxCUI 1668237In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 1668238 -
Dose form (SCDF) Ophthalmic Solution RxCUI 706867In current FDA listingsClinical drug / strength (SCD) 10 MG/MLRxCUI 706868 -
Dose form (SCDF) Oral Capsule RxCUI 370974No current FDA listingClinical drug / strength (SCD) 250 MGRxCUI 141962 -
Dose form (SCDF) Oral Suspension RxCUI 370975In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 370976In current FDA listings -
Dose form (SCDF) Powder for Oral Suspension RxCUI 1807494In current FDA listingsClinical drug / strength (SCD) 1000 MGRxCUI 861416
Look up RxCUI 18631 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Azithromycin supply and shortage status
Whether Azithromycin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Azithromycin costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 250 mg | $2.07–$2.08 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 600 mg | $0.715 per tablet | NDC details & price history |
| Powder, For Suspension · Oral | 100 mg/5 mL | $0.370 per mL | NDC details & price history |
| Injection, Powder, Lyophilized, For Solution · Intravenous | 500 mg | $3.53 each | NDC details & price history |
| Tablet · Oral | 500 mg | $0.541 per tablet | NDC details & price history |
| Tablet · Oral | 250 mg | $0.266 per tablet | NDC details & price history |
| Tablet · Oral | 600 mg | $0.715 per tablet | NDC details & price history |
| Powder, For Suspension · Parenteral | 200 mg/5 mL | $0.205 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Azithromycin brand names
Azithromycin is sold under 6 brand names in the FDA directory — Zithromax, Zithromax Single Dose Packets, Zithromax Tri-Paks, Zithromax Z-Paks and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Azithromycin: manufacturers and labelers
53 companies list Azithromycin products with the FDA. By number of product records, the largest are A-S Medication Solutions, Proficient Rx LP, NuCare Pharmaceuticals,Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 29 more on the FDA NDC directory.
Azithromycin drug class (RxNorm)
Azithromycin belongs to the Macrolide Antimicrobial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Azithromycin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. RedPharm Drug, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →