Prescription medicine
Cefuroxime First approved as Zinacef
Cefuroxime (Zinacef) is a prescription medicine with an FDA approval on record since 1983. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $0.280 per cefuroxime axetil 250 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cefuroxime FDA label on DailyMed (effective April 29, 2024, Aurobindo Pharma Limited); the NDA 50558 record on Drugs@FDA; every cefuroxime label on DailyMed.
Highlights of the record
FDA label of April 29, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: ( 1 ) Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1 ) Acute bacterial otitis media (pediatric patients) ( 1.2 ) Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3 ) Acute bacterial exacerbations of chronic bronchitis (adults and pe
Forms and strengths
- 1.5 g
- 7.5 g
- 125 mg
- 250 mg
- 500 mg
- 750 mg
- 1.5 g/20ml
- 1.5 g/50ml
- 750 mg/50ml
- 750 mg/8ml
Film-coated tablet; tablet; injection (powder) for solution; injection (solution).
On the market
- Earliest approval on file
- October 19, 1983 Zinacef, Pai Holdings Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 28 first January 10, 1986; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 19 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.280 per tablet Cefuroxime axetil 250 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2016 0 Class I among all firms' recalls; latest December 6, 2021; 5 more by firms not listed as its makers
- FAERS reports
- 15,670 through July 30, 2026
What is cefuroxime used for?
From the label: indications and usageCefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: ( 1 ) Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1 ) Acute bacterial otitis media (pediatric patients) ( 1.2 ) Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3 ) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4 ) Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5 ) Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6 ) Uncomplicated gonorrhea […]
Conditions named in the indications of cefuroxime's FDA labels, with every medicine labeled for each:
From other cefuroxime labelsBacterial infections: … pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of Staphylococcus aureus (including β - lactamase–producing strains) or Streptococcus pyogenes.
Urinary tract infections: Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coli or Klebsiella pneumoniae.
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (Cefuroxime Axetil), Aurobindo Pharma Limited, effective April 29, 2024 (SPL set faef39e9-d793-4191-a728-310f6fab759d), via openFDA; the full label on DailyMed
Is there a generic for cefuroxime (Zinacef)?
The FDA approved the first generic cefuroxime on January 10, 1986. 28 generic applications are approved; 6 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 cefuroxime from 19 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1983 earliest approval on file
- 1986 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 cefuroxime (Zinacef)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.280 per Cefuroxime axetil 250 mg tablet, down 3% from $0.290 on October 8, 2025. 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.
- Cefuroxime axetil 250 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cefuroxime axetil 250 mg tablet | Generic | $0.280 per tablet | $8.39 | -3% |
| Cefuroxime axetil 500 mg tablet | Generic | $0.366 per tablet | $10.97 | -17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cefuroxime been recalled?
The FDA's Enforcement Report lists 6 recalls naming cefuroxime since 2016: 0 Class I (the most serious), 5 Class II, 1 Class III; 0 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of cefuroxime and that hold 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 |
|---|---|---|---|
| October 2, 2023 | Class II | Pine Pharmaceuticals, LLC not a listed maker | Lack of Assurance of Sterility |
| December 6, 2021 | Class II | Edge Pharma, LLC | Lack of Assurance of Sterility |
| February 19, 2019 | Class II | Leiter's Enterprises, Inc. not a listed maker | Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride. |
| August 23, 2018 | Class II | Pacific Compounding Pharmacy & Consultations Inc not a listed maker | Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. … |
| January 24, 2018 | Class III | JCB Laboratories LLC not a listed maker | Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date. |
| September 20, 2016 | Class II | Leiter's Compounding not a listed maker | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cefuroxime label say about other medicines?
The cefuroxime label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name cefuroxime. 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 |
|---|---|---|
| Probenecid | drug interactions | DRUG INTERACTIONS Drugs that reduce gastric acidity may lower the bioavailability of cefuroxime axetil. ( 7.1 ) Coadministration with probenecid increases systemic exposure to cefuroxime axetil and is therefore not recommended. |
Source: FDA drug label (Cefuroxime Axetil), Aurobindo Pharma Limited, effective April 29, 2024 (SPL set faef39e9-d793-4191-a728-310f6fab759d), via openFDA; the full label on DailyMed
What do FAERS reports show for cefuroxime?
The FDA Adverse Event Reporting System holds 15,670 reports that list cefuroxime among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,686 are coded as a death and 6,881 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 cefuroxime?
26 other medicines are given the same way (oral) and in the same FDA class as cefuroxime 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 |
|---|---|---|---|---|
| Cephalexin | Bacterial infections, Urinary tract infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Cefdinir | Bacterial infections | 26 labelers | $0.458 per capsule 300 mg capsule | No current entry |
| Cefadroxil | Bacterial infections, Urinary tract infections | 19 labelers | $0.269 per capsule 500 mg capsule | No current entry |
| Cefpodoxime | Bacterial infections | 11 labelers | $1.04 per tablet 100 mg tablet | No current entry |
| Cefprozil | Bacterial infections | 7 labelers | $0.925 per tablet 500 mg tablet | No current entry |
| Cefixime | Bacterial infections, Urinary tract infections | 6 labelers | $10.03 per capsule 400 mg capsule | No current entry |
| Doxycycline | Bacterial infections, Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
Every medicine labeled for the same conditions as cefuroxime
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cefuroxime compare with medicines for the same use?
23 side-by-side pages set cefuroxime beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cefuroxime
- 26 medicines for the same use
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Cefuroxime side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other