Prescription medicine
Fidaxomicin Brand names: Dificid
Fidaxomicin (Dificid) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $90.50 per fidaxomicin 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the fidaxomicin FDA label on DailyMed (effective October 16, 2024, Merck Sharp & Dohme LLC); the NDA 201699 record on Drugs@FDA; every fidaxomicin label on DailyMed.
Highlights of the record
FDA label of October 16, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDIFICID is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of C.
Forms and strengths
- 200 mg
- 200 mg/5ml
Film-coated tablet; granule for suspension.
On the market
- Earliest approval on file
- May 27, 2011 Dificid, Cubist Pharms Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first January 16, 2024; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 31, 2028 Dificid tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $90.50 per tablet Fidaxomicin 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 2,385 through July 30, 2026
What is fidaxomicin used for?
From the label: indications and usageDIFICID is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of C. difficile -associated diarrhea. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile. […]
FDA pharmacologic class: Macrolide Antibacterial.
Source: FDA drug label (Dificid), NDA201699 (Cubist Pharms Llc), as published by Merck Sharp & Dohme LLC, effective October 16, 2024 (SPL set dd966338-c820-4270-b704-09ef75fa3ceb), via openFDA; the full label on DailyMed
Is there a generic for fidaxomicin (Dificid)?
The FDA approved the first generic fidaxomicin on January 16, 2024. 4 generic applications are approved; 4 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 fidaxomicin from 4 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.
The Orange Book lists 4 patents for Dificid tablets: the compound patent runs to July 31, 2027 (pediatric exclusivity to January 31, 2028); a patent listed only for Dificid for oral suspension runs to November 28, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2024 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 fidaxomicin (Dificid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $90.50 per Fidaxomicin 200 mg tablet, down 50% from $182.83 on November 19, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Fidaxomicin 200 mg tablet (generic)
- Dificid 200 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fidaxomicin 200 mg tablet | Generic | $90.50 per tablet | $2,715.14 | -50% |
| Dificid 200 mg tablet | Brand | $248.38 per tablet | $7,451.36 | -0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fidaxomicin been recalled?
The FDA's Enforcement Report lists 1 recall naming fidaxomicin since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of fidaxomicin 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 |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; FIDAXOMICIN Tablet, 200 mg may be potentially mislabeled as BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: W003918, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fidaxomicin label say about other medicines?
The fidaxomicin label names 1 other medicine 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 |
|---|---|---|
| Cyclosporine | drug interactions | Cyclosporine is an inhibitor of multiple transporters, including P-gp. |
Source: FDA drug label (Dificid), NDA201699 (Cubist Pharms Llc), as published by Merck Sharp & Dohme LLC, effective October 16, 2024 (SPL set dd966338-c820-4270-b704-09ef75fa3ceb), via openFDA; the full label on DailyMed
What do FAERS reports show for fidaxomicin?
The FDA Adverse Event Reporting System holds 2,385 reports that list fidaxomicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 257 are coded as a death and 747 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 next?
- Fidaxomicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other