Prescription medicine
Cefaclor First approved as Ceclor
Cefaclor (Ceclor) is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $0.932 per cefaclor 250 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cefaclor FDA label on DailyMed (effective November 1, 2022, Azorian Pharma, LLC); the NDA 50522 record on Drugs@FDA; every cefaclor label on DailyMed.
Highlights of the record
FDA label of November 1, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptib
Forms and strengths
- 250 mg
- 500 mg
- 250 mg/5ml
Capsule; film-coated extended-release tablet; suspension.
On the market
- Earliest approval on file
- April 4, 1979 Ceclor, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 30 first April 23, 1979; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.932 per capsule Cefaclor 250 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,535 through July 30, 2026
What is cefaclor used for?
From the label: indications and usageCefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. […]
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (Cefaclor), Azorian Pharma, LLC, effective November 1, 2022 (SPL set 224af904-38f3-4210-a750-e21006db4c66), via openFDA; the full label on DailyMed
Is there a generic for cefaclor (Ceclor)?
The FDA approved the first generic cefaclor on April 23, 1979. 30 generic applications are approved; 3 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 cefaclor from 4 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.
- 1979 earliest approval on file
- 1979 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cefaclor (Ceclor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.932 per Cefaclor 250 mg capsule, down 1% from $0.942 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.
- Cefaclor 250 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cefaclor 250 mg capsule | Generic | $0.932 per capsule | $27.97 | -1% |
| Cefaclor 500 mg capsule | Generic | $1.10 per capsule | $32.99 | -21% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the cefaclor label say about other medicines?
The cefaclor label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 6 other medicines name cefaclor. 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 |
|---|---|---|
| Epinephrine | warnings | SERIOUS ACUTE HYPER-SENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. |
Other labels that name cefaclor
Source: FDA drug label (Cefaclor), Azorian Pharma, LLC, effective November 1, 2022 (SPL set 224af904-38f3-4210-a750-e21006db4c66), via openFDA; the full label on DailyMed
What do FAERS reports show for cefaclor?
The FDA Adverse Event Reporting System holds 1,535 reports that list cefaclor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 148 are coded as a death and 695 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?
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Cefaclor side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other