Prescription medicine
Azithromycin Brand names: Zithromax, Azasite
Azithromycin (Zithromax) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 55 generic labelers, and pharmacies paid $0.266 per azithromycin 250 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $98.51 per mL (Azasite 1% eye drops).
- Generic listed
- A presentation discontinued
Check it at the source: the azithromycin FDA label on DailyMed (effective December 4, 2025, Bionpharma Inc.); the NDA 50670 record on Drugs@FDA; every azithromycin label on DailyMed.
Highlights of the record
FDA label of December 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAzithromycin tablets are macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
Forms and strengths
- 250 mg
- 500 mg
- 600 mg
- 10 mg/ml
- 100 mg/5ml
- 200 mg/5ml
- 500 mg/5ml
- 500 mg/10ml
Film-coated tablet; powder for suspension; injection (powder) (lyophilized) for solution; tablet; suspension.
On the market
- Earliest approval on file
- November 1, 1991 Zithromax, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 62 first November 14, 2005; 39 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 57 of which 55 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.266 per tablet Azithromycin 250 mg tablet
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 11 since 2014 0 Class I among all firms' recalls; latest April 13, 2022; 1 more by firms not listed as its makers
- FAERS reports
- 59,712 through July 30, 2026
What is azithromycin used for?
From the label: indications and usageAzithromycin tablets are macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. […]
Conditions named in the indications of azithromycin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Macrolide Antimicrobial.
Source: FDA drug label (Azithromycin), Bionpharma Inc., effective December 4, 2025 (SPL set 859bb02c-a4bc-46fa-9fc9-def1219b5dfb), via openFDA; the full label on DailyMed
Is there a generic for azithromycin (Zithromax)?
The FDA approved the first generic azithromycin on November 14, 2005. 62 generic applications are approved; 39 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists azithromycin from 55 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 2005 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for azithromycin (Zithromax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.266 per Azithromycin 250 mg tablet, down 26% from $0.358 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Azithromycin 250 mg tablet (generic)
- Azasite 1% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Azithromycin 100 mg/5 mL suspension | Generic | $0.370 per mL | n/a | -3% |
| Azithromycin 200 mg/5 mL suspension | Generic | $0.238 per mL | n/a | +0.1% |
| Azithromycin 250 mg tablet | Generic | $0.266 per tablet | $7.97 | -26% |
| Azithromycin 500 mg tablet | Generic | $0.541 per tablet | $16.23 | -18% |
| Azithromycin 600 mg tablet | Generic | $0.715 per tablet | $21.44 | -37% |
| Azasite 1% eye drops | Brand | $98.51 per mL | n/a | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is azithromycin in shortage?
No azithromycin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated April 9, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Zithromax IV, Injection, 500 mg/5 mL (NDC 0069-3150-83) | Pfizer Inc. | To Be Discontinued | January 20, 2026 |
| Zithromax, Tablet, 250 mg (NDC 0069-4061-01) | Pfizer Inc. | To Be Discontinued | April 9, 2026 |
| Zithromax, Tablet, 500 mg (NDC 0069-3070-30) | Pfizer Inc. | To Be Discontinued | April 9, 2026 |
Every azithromycin presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has azithromycin been recalled?
The FDA's Enforcement Report lists 12 recalls naming azithromycin since 2014: 0 Class I (the most serious), 11 Class II, 1 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of azithromycin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| April 3, 2018 | Class II | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. |
| June 1, 2015 | Class II | American Health Packaging | CGMP Deviations: Firm did not adequately investigate customer complaints. |
| April 29, 2015 | Class II | PD-Rx Pharmaceuticals, Inc. | cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints. |
| April 22, 2015 | Class II | Wockhardt Usa Inc. | CGMP Deviations: Firm did not adequately investigate customer complaints. |
| February 12, 2015 | Class II | Health Innovations Pharmacy, Inc not a listed maker | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures … |
| January 2, 2014 | Class III | Pfizer Inc. | Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the azithromycin label say about other medicines?
The azithromycin label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 26 other medicines name azithromycin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | … significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. |
| Amoxicillin | warnings and precautions | Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. |
| Colchicine | drug interactions | Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised. |
| Digoxin | drug interactions | Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised. |
| Dofetilide | warnings and precautions | … clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. |
| Erythromycin | contraindications | CONTRAINDICATIONS Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. ( 4.1 ) Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. |
| Fluorescein | warnings and precautions | Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and where appropriate, fluorescein staining. |
| Nelfinavir | drug interactions | DRUG INTERACTIONS Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. |
| Phenytoin | drug interactions | Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised. |
| Procainamide | warnings and precautions | … hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. |
| Quinidine | warnings and precautions | … uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. |
| Sotalol | warnings and precautions | … bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. |
| Warfarin | drug interactions | 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. |
Other labels that name azithromycin
Source: FDA drug label (Azithromycin), Bionpharma Inc., effective December 4, 2025 (SPL set 859bb02c-a4bc-46fa-9fc9-def1219b5dfb), via openFDA; the full label on DailyMed
What do FAERS reports show for azithromycin?
The FDA Adverse Event Reporting System holds 59,712 reports that list azithromycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,260 are coded as a death and 22,121 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as azithromycin?
23 other medicines are given the same way (oral) and in the same FDA class as azithromycin or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erythromycin | Bacterial infections | 22 labelers | $1.96 per tablet 250 mg tablet | No current entry |
| Clarithromycin | Bacterial infections | 26 labelers | $0.466 per tablet 500 mg tablet | No current entry |
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Cephalexin | Bacterial infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Metronidazole | Bacterial infections | 40 labelers | $0.102 per tablet 250 mg tablet | In shortage |
| Clindamycin | Bacterial infections | 40 labelers | $0.103 per capsule 150 mg capsule | In shortage |
| Sulfamethoxazole and trimethoprim | Bacterial infections | 42 labelers | $0.0448 per tablet Sulfamethoxazole-tmp ds tablet | No current entry |
| Levofloxacin | Bacterial infections | 35 labelers | $0.259 per tablet 750 mg tablet | No current entry |
Every medicine labeled for the same conditions as azithromycin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does azithromycin compare with medicines for the same use?
22 side-by-side pages set azithromycin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to azithromycin
- 23 medicines for the same use
- Other macrolides
- the pharmacologic class, with prices and generics
- Azithromycin side effects
- the label's list beside FAERS reports
- Azithromycin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other