Prescription medicine
Cefixime First approved as Suprax
Cefixime (Suprax) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $10.03 per cefixime 400 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cefixime FDA label on DailyMed (effective August 5, 2026, REMEDYREPACK INC.); the NDA 50622 record on Drugs@FDA; every cefixime label on DailyMed.
Highlights of the record
FDA label of August 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections ( 1.1 ) Otitis Media ( 1.2 ) Pharyngitis and Tonsillitis ( 1.3 ) Acute Exacerbations of Chronic Bronchitis ( 1.4 ) Uncomplicated Gonorrhea (cervical/urethral) ( 1.5 ) Usage to Reduce Development of Drug-Resistant Bacteria
Forms and strengths
- 400 mg
- 100 mg/5ml
- 200 mg/5ml
Capsule; powder for suspension; tablet.
On the market
- Earliest approval on file
- April 28, 1989 Suprax, Lederle; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first February 12, 2004; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- December 14, 2028 Suprax for oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $10.03 per capsule Cefixime 400 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2020 0 Class I among all firms' recalls; latest August 21, 2024
- FAERS reports
- 2,959 through July 30, 2026
What is cefixime used for?
From the label: indications and usageCefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections ( 1.1 ) Otitis Media ( 1.2 ) Pharyngitis and Tonsillitis ( 1.3 ) Acute Exacerbations of Chronic Bronchitis ( 1.4 ) Uncomplicated Gonorrhea (cervical/urethral) ( 1.5 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime for oral suspension and cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. […]
Conditions named in the indications of cefixime's FDA labels, with every medicine labeled for each:
From other cefixime labelsBacterial infections and Urinary tract infections: … and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis.
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (CEFIXIME), NDA203195 (Lupin Ltd), as published by REMEDYREPACK INC., effective August 5, 2026 (SPL set 3194433c-c04e-442b-9668-fbeb0a15bac7), via openFDA; the full label on DailyMed
Is there a generic for cefixime (Suprax)?
The FDA approved the first generic cefixime on February 12, 2004. 13 generic applications are approved; 9 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 cefixime from 6 labelers 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.
The Orange Book lists no patent for Suprax capsules; a patent listed only for Suprax for oral suspension runs to December 14, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1989 earliest approval on file
- 2004 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cefixime (Suprax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $10.03 per Cefixime 400 mg capsule, 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.
- Cefixime 400 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cefixime 100 mg/5 mL suspension | Generic | $2.44 per mL | n/a | +10% |
| Cefixime 200 mg/5 mL suspension | Generic | $3.43 per mL | n/a | -37% |
| Cefixime 400 mg capsule | Generic | $10.03 per capsule | $300.85 | -0.6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cefixime been recalled?
The FDA's Enforcement Report lists 8 recalls naming cefixime since 2020: 0 Class I (the most serious), 8 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 21, 2024 | Class II | Lupin Pharmaceuticals Inc. | Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study. |
| May 30, 2024 | Class II | Lupin Pharmaceuticals Inc. | Failed Content Uniformity Specifications |
| January 3, 2024 | Class II | Lupin Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications |
| December 29, 2021 | Class II | RemedyRepack Inc. | Failed Impurities/Degradation Specifications |
| December 21, 2021 | Class II | Ascend Laboratories, LLC | Failed impurities/degradation specifications |
| November 3, 2021 | Class II | Ascend Laboratories LLC | Failed Impurities/Degradation Specifications |
| April 29, 2021 | Class II | Lupin Pharmaceuticals Inc. | Subpotent Drug |
| April 15, 2020 | Class II | Lupin Pharmaceuticals Inc. | Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cefixime label say about other medicines?
The cefixime label names 2 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 named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations. |
| Warfarin | drug interactions | DRUG INTERACTIONS Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. ( 7.1 ) Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly with warfarin and anticoagulants. |
Source: FDA drug label (CEFIXIME), NDA203195 (Lupin Ltd), as published by REMEDYREPACK INC., effective August 5, 2026 (SPL set 3194433c-c04e-442b-9668-fbeb0a15bac7), via openFDA; the full label on DailyMed
What do FAERS reports show for cefixime?
The FDA Adverse Event Reporting System holds 2,959 reports that list cefixime among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 197 are coded as a death and 1,372 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 cefixime?
26 other medicines are given the same way (oral) and in the same FDA class as cefixime 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 |
| Cefuroxime | Bacterial infections, Urinary tract infections | 17 labelers | $0.280 per tablet 250 mg tablet | 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 |
| 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cefixime compare with medicines for the same use?
19 side-by-side pages set cefixime beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cefixime
- 26 medicines for the same use
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Cefixime side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other