Skip to the answer

Cefaclor

Cefaclor is an oral cephalosporin antibiotic used to treat bacterial infections including ear infections, respiratory tract infections, urinary tract infections, skin infections, and strep throat.

Brand names CeclorCeclor CDRaniclor
Drug class Cephalosporin Antibacterial
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Cefaclor at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Cefaclor is an older cephalosporin antibiotic, on the U.S. market since about 1979 and available as a generic, that kills bacteria by blocking how they build their cell walls. It treats ear, throat, lung, urinary and skin infections, though today it is usually not the first antibiotic prescribers reach for. Most people handle it well, and the side effects they notice are diarrhea, nausea and stomach pain, plus a vaginal yeast infection for some women. The one thing to look for is an allergic reaction, so tell your prescriber about any penicillin or cephalosporin allergy first, and get emergency care for hives, facial or throat swelling, or trouble breathing.

Clinical pearls

  • Take the extended-release tablet with a meal, swallow it whole, and keep magnesium or aluminum antacids an hour away.
  • Watery or bloody diarrhea, even weeks after finishing, can mean C. difficile, a serious gut infection, so call promptly.
  • Cefaclor can cause a serum-sickness-like reaction (joint pain and rash, sometimes fever), especially on a second course.
  • For strep throat, finish the full course even if you feel better, since stopping early lets the infection come back.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asCapsule, Extended-release tablet, Oral suspension
Earliest FDA record1979
Companies listing it with the FDA4
FDA label last updatedJul 31, 2019
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Cefaclor, written from its FDA label.

What Cefaclor is used for

▾

Cefaclor is an oral cephalosporin antibiotic approved to treat bacterial infections across several forms — capsule, oral suspension, and extended-release tablet. Not every form is approved for every use.

  • Ear infections (otitis media) — Cefaclor capsule and oral suspension are approved for this use
  • Lower respiratory tract infections, including pneumonia — Cefaclor capsule and oral suspension are approved for this use
  • Strep throat and tonsillitis — all three forms (capsule, oral suspension, and extended-release tablet) are approved
  • Urinary tract infections (including kidney infections and bladder infections) — Cefaclor capsule and oral suspension are approved
  • Skin and skin structure infections — Cefaclor capsule and oral suspension are approved; Cefaclor extended-release tablet is approved specifically for uncomplicated skin infections caused by methicillin-susceptible Staphylococcus aureus
  • Acute bacterial flare-ups of chronic bronchitis — Cefaclor extended-release tablet is approved for mild to moderate cases caused by certain bacteria

How Cefaclor works

▾

Cefaclor belongs to the cephalosporin class of antibiotics. It works by interfering with the way bacteria build their cell walls — specifically by blocking proteins the bacteria need for wall construction. Without a stable cell wall, bacteria cannot survive, so the infection clears. This is a bactericidal effect, meaning it actually kills the bacteria rather than just slowing their growth.

Some bacteria are naturally resistant to cefaclor. Resistance can happen when bacteria produce enzymes called beta-lactamases that break down the drug, when they change the proteins cefaclor normally targets, or when they block the drug from entering the cell. Cefaclor does not work against methicillin-resistant staphylococci or certain other bacteria types, which is why your doctor may order a culture test to confirm the right antibiotic for your infection.

Cefaclor dosage

▾

Cefaclor is always taken by mouth. The capsule and oral suspension are generally taken three times a day (roughly every 8 hours) and can be taken with or without food. The extended-release tablet is taken twice a day and must be taken with a meal — food is essential for proper absorption with this form. Extended-release tablets must be swallowed whole; do not cut, crush, or chew them.

  • For strep throat infections, the full course is usually at least 10 days — finish even if you feel better sooner
  • If you miss a dose, take it as soon as you remember — but if it's almost time for your next dose, skip the missed one and continue your regular schedule
  • Cefaclor may generally be used in patients with reduced kidney function, but your prescriber will determine the appropriate approach

Dosing details from the FDA-approved label

From the Cefaclor prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults (oral suspension and capsule)
    • The usual adult dosage is 250 mg every 8 hours
    • For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled
    • Dosage usually unchanged in impaired renal function
  • Pediatric patients, usual dosage
    • 20 mg/kg/day in divided doses every 8 hours
    • Suspension table: 9 kg, 125 mg/5 mL, 1/2 tsp t.i.d.; 18 kg, 125 mg/5 mL, 1 tsp t.i.d. or 250 mg/5 mL, 1/2 tsp t.i.d.
  • Pediatric patients, more serious infections, otitis media, and infections caused by less susceptible organisms
    • 40 mg/kg/day
    • Maximum: 1 g/day
    • Suspension table: 9 kg, 125 mg/5 mL, 1 tsp t.i.d. or 250 mg/5 mL, 1/2 tsp t.i.d.; 18 kg, 250 mg/5 mL, 1 tsp t.i.d.
  • Otitis media and pharyngitis (treatment option, oral suspension)
    • Total daily dosage may be divided and administered every 12 hours. 20 mg/kg/day (pharyngitis): 18 kg, 375 mg/5 mL, 1/2 tsp b.i.d. 40 mg/kg/day (otitis media): 9 kg, 1/2 tsp b.i.d
    • 18 kg, 1 tsp b.i.d
  • β-hemolytic streptococcal infections
    • A therapeutic dosage of cefaclor should be administered for at least 10 days
  • Adults (16 years and older), extended-release tablets: acute bacterial exacerbations of chronic bronchitis due to H. influenzae (non-ß-lactamase-producing strains only), Moraxella catarrhalis, or Streptococcus pneumoniae
    • 500 mg q 12 hours for 7 days (total daily dose 1000 mg)
    • Administer with meals (at least within one hour of eating); do not cut, crush, or chew
  • Adults (16 years and older), extended-release tablets: pharyngitis and/or tonsillitis due to S. pyogenes
    • 375 mg q 12 hours for 10 days (total daily dose 750 mg)
    • Administer with meals (at least within one hour of eating)
  • Adults (16 years and older), extended-release tablets: uncomplicated skin and skin structure infections due to S. aureus (methicillin-susceptible strains)
    • 375 mg q 12 hours for 7 to 10 days (total daily dose 750 mg)
    • Elderly patients with normal renal function do not require dosage adjustments
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Cefaclor is administered orally. Adults -- The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled. Pediatric Patients -- The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day. Table 1: Cefaclor for Oral Suspension, USP 20 mg/kg/day Weight 125 mg/5 mL 250 mg/5 mL 9 kg 1/2 tsp t.i.d. 18 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 40 mg/kg/day 9 kg 1 tsp t.i.d. 1/2 tsp t.i.d. 18 kg 1 tsp t.i.d. B.I.D. Treatment Option —For the treatment of otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours. Table 2: Cefaclor for Oral Suspension, USP 20 mg/kg/day (Pharyngitis) Weight 375 mg/5 mL 18 kg 1/2 tsp b.i.d. 40 mg/kg/day (Otitis Media) 9 kg 1/2 tsp b.i.d. 18 kg 1 tsp b.i.d. Cefaclor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see PRECAUTIONS ). In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days. Directions for Mixing: Add appropriate water volume as indicated in the following table in two portions to dry mixture in the bottle. Shake well after each addition. Each 5 mL (approximately one teaspoonful) will then contain Cefaclor, USP, monohydrate equivalent to 250 mg anhydrous cefaclor, respectively, as shown in the following table. Oversize bottle provides extra space for shaking. Table 3: Cefaclor For Oral Suspension, USP Strength Package Size (when mixed) Water Volume to Add Anhydrous Cefaclor/5 mL (approx. one teaspoonful) 250 mg/5 Ml 150 mL 106 mL 250 mg

Read the full Dosage and Administration section on DailyMed →

Cefaclor side effects

▾

The most commonly reported side effects with cefaclor include:

Common side effects

  • Diarrhea
  • Nausea or vomiting
  • Headache
  • Abdominal pain
  • Itching (pruritus)
  • Vaginal yeast infection (vaginitis or vaginal moniliasis)
  • Runny nose (rhinitis)

When to get medical help

  • Signs of a severe allergic reaction — rash, hives, swelling of the face or throat, difficulty breathing, or fainting — seek emergency care immediately
  • Persistent or severe diarrhea, or diarrhea with blood or mucus, which may signal a serious gut infection (C. difficile)
  • Skin blistering or peeling, which could signal a rare but serious skin reaction such as Stevens-Johnson syndrome
  • Serum-sickness-like reaction — joint pain, rash, or skin changes with or without fever, especially after a second course of cefaclor
  • Signs of a serious kidney or liver problem — unusual swelling, dark urine, or yellowing of the skin

Most side effects are mild and go away on their own. However, contact your doctor right away if you develop severe or prolonged diarrhea, signs of an allergic reaction (hives, swelling, difficulty breathing), skin blistering or peeling, or joint pain accompanied by a rash — especially after a second course of cefaclor, as these can be signs of a more serious reaction.

Cefaclor warnings and precautions

▾
  • Allergic reactions: Severe allergic reactions including anaphylaxis (sudden, life-threatening allergic response) have been reported. If you have a penicillin allergy, there is a meaningful chance you may also react to cefaclor. Tell your doctor about any antibiotic allergies before starting.
  • C. difficile-associated diarrhea (CDAD): Antibiotics can disrupt your gut's normal bacteria and allow C. difficile bacteria to overgrow. This can cause severe diarrhea or colitis (gut inflammation). It can occur during treatment or up to two months after finishing. Persistent or bloody diarrhea after any antibiotic use should always be reported to your doctor.
  • Serum-sickness-like reactions: A small number of patients — more often children — develop a reaction involving rash, joint pain, and sometimes fever, typically a few days into treatment. It's more likely after a repeat course of cefaclor. These reactions usually resolve once the drug is stopped but have occasionally required brief hospitalization.
  • Serious skin reactions: Rare but severe skin reactions such as Stevens-Johnson syndrome have been reported. Seek immediate medical attention for any blistering, peeling, or widespread rash.

Cefaclor interactions

▾

Cefaclor has a few important interactions to be aware of:

  • Antacids (containing magnesium or aluminum hydroxide): These can reduce how much of the extended-release tablet your body absorbs — avoid taking them within 1 hour of your dose. H2 blockers (a different type of acid reducer) do not appear to affect absorption.
  • Probenecid (used for gout): This drug slows the kidneys from clearing cefaclor, which may raise cefaclor levels in your blood. Let your prescriber know if you take it.
  • Warfarin (blood thinner): There have been rare reports of increased bleeding or higher warfarin effect when taken alongside cefaclor. Your doctor may want to monitor your blood clotting levels more closely during your antibiotic course.

Interactions listed in the FDA-approved label

From the Cefaclor prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Antacids (magnesium or aluminum hydroxide-containing): The extent of absorption of cefaclor extended-release tablets is diminished if these antacids are taken within 1 hour of administration.
  • H2 blockers: H2 blockers do not alter either the rate or the extent of absorption of cefaclor extended-release tablets.
  • Probenecid: The renal excretion of cefaclor is inhibited by probenecid.
  • Warfarin: There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving cefaclor and warfarin concomitantly. No specific studies have been performed to rule in or rule out this potential drug/drug interaction.
Read the label’s full interactions text

Drug Interactions Antacids The extent of absorption of cefaclor extended-release tablets is diminished if magnesium or aluminum hydroxide-containing antacids are taken within 1 hour of administration; H 2 blockers do not alter either the rate or the extent of absorption of cefaclor extended-release tablets. Probenecid The renal excretion of cefaclor is inhibited by probenecid. Warfarin There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving cefaclor and warfarin concomitantly. No specific studies have been performed to rule in or rule out this potential drug/drug interaction.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿60 supplements and herbs with documented Cefaclor interactions, ranked by severity Check Cefaclor against a supplement or herb →

Before taking Cefaclor

▾
  • Tell your doctor if you have ever had an allergic reaction to a cephalosporin or penicillin antibiotic — cross-allergy is possible in up to 10% of penicillin-allergic patients
  • Tell your doctor about all drug allergies, including non-antibiotic drugs
  • If you have reduced kidney function, let your prescriber know — cefaclor stays in the body longer and the half-life is extended
  • If you have a history of colitis or other gastrointestinal disease, discuss this with your doctor before starting
  • Cefaclor extended-release tablets are approved for adults age 16 and older; the capsule and oral suspension have dosing guidance for children
  • Elderly patients with normal kidney function do not require dose adjustments for the extended-release tablet form
  • Tell your prescriber about all medications you currently take, especially probenecid or warfarin
  • Do not use cefaclor if you have a known allergy to cefaclor or other cephalosporin antibiotics

Cefaclor overdose

▾

Taking too much cefaclor can cause nausea, vomiting, stomach pain, and diarrhea — and the stomach symptoms tend to get worse with higher amounts. If you think you or someone else has taken too much, contact a Poison Control Center right away for guidance. Do not try to make the person vomit unless instructed by a medical professional.

What Cefaclor does in the body

▾

Cefaclor exerts a bactericidal (bacteria-killing) effect by blocking bacterial cell wall synthesis. It is active against a range of gram-positive and gram-negative bacteria, including Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Haemophilus influenzae, Klebsiella species, and Proteus mirabilis. It is not effective against methicillin-resistant staphylococci, Pseudomonas species, Enterococcus faecalis, or several other resistant organisms.

How your body processes Cefaclor

▾

Cefaclor is well absorbed after oral administration. When taken on an empty stomach, it reaches peak blood levels within 30 to 60 minutes. Taking it with food does not reduce the total amount absorbed overall, but it does slow absorption and lowers the peak concentration. The drug has a short half-life of about 0.6 to 0.9 hours in people with normal kidney function. Between 60% and 85% of cefaclor is excreted unchanged in the urine within 8 hours, making the kidneys the primary route of elimination. In patients with severely impaired kidney function, the half-life is extended to about 2.3 to 2.8 hours, and hemodialysis can shorten the half-life by 25% to 30%.

How to store Cefaclor

▾

Store at 20 - 25℃ (68 to 77℉) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

60

Supplements & herbs that interact with Cefaclor

60 supplements and herbal products have documented interactions with Cefaclor in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 46
  • Minor · 11
ACTIVATED CHARCOAL Major ASARABACCA Major SIBERIAN COCKLEBUR Major AFRICAN WILD POTATO Moderate ARISTOLOCHIA Moderate BACILLUS COAGULANS Moderate Bacillus Subtilis Moderate Banderol Moderate +52 more
Every supplement checked against Cefaclor — ranked by severity The full interaction hub: 3 major · 46 moderate · 11 minor · every one linked to its full report. Check Cefaclor against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

7

Nutrient depletion considerations

Cefaclor has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 6
  • Moderate · 1
BIOTIN Insignificant Depletion FOLIC ACID Insignificant Depletion RIBOFLAVIN Insignificant Depletion THIAMINE Insignificant Depletion VITAMIN B12 Insignificant Depletion VITAMIN B6 Insignificant Depletion VITAMIN K Moderate Depletion
See the full Cefaclor nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Cefaclor: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Cefaclor — the kind of thing our pharmacy team would talk through with you at the counter.

What kinds of infections does cefaclor treat?

▾
Cefaclor treats a variety of common bacterial infections. Depending on the form prescribed, it can be used for ear infections, strep throat and tonsillitis, pneumonia and other lower respiratory infections, urinary tract infections (including kidney infections), and skin infections. The extended-release tablet covers a somewhat narrower list — mainly chronic bronchitis flare-ups, strep throat, and certain skin infections — so the form your doctor chose matters.

Do I need to take it with food?

▾
It depends on the form you have. If you're taking the extended-release tablet, you should take it with food — within about an hour of eating — because food helps your body absorb it properly. The capsule and oral suspension can be taken with or without food. Check your prescription label, and when in doubt, ask your pharmacist.

What side effects should I expect, and which ones mean I should call my doctor?

▾
The most common side effects are diarrhea, nausea, headache, and stomach discomfort — most are mild and settle down as your body adjusts. Women may notice a vaginal yeast infection. You should call your doctor right away if you develop severe or persistent diarrhea (especially with blood or mucus), a rash with joint pain or fever, blistering or peeling skin, or any signs of a serious allergic reaction like swelling of the face or throat or trouble breathing. Those need prompt attention.

I'm allergic to penicillin — is it safe for me to take cefaclor?

▾
This is a really important thing to tell your doctor. Cefaclor and penicillin are both in the beta-lactam antibiotic family, and up to 1 in 10 people with a penicillin allergy may also react to cefaclor. That doesn't automatically mean you can't take it — your doctor will weigh the risk based on the type of reaction you had before. Never start cefaclor without telling your prescriber about any antibiotic allergy first.

Can I stop taking it once I feel better?

▾
Please don't stop early, even if you feel completely better. For strep throat infections especially, you need to take cefaclor for at least 10 days to fully clear the bacteria. Stopping too soon can allow the infection to come back, sometimes harder to treat. Finish the full course your doctor prescribed.

Is it okay to take antacids while I'm on cefaclor?

▾
If you're taking the extended-release tablet, you should avoid antacids that contain magnesium or aluminum (like Maalox or Mylanta) within 1 hour of your cefaclor dose — they can reduce how much of the antibiotic your body absorbs. H2 blockers like famotidine (Pepcid) are fine and don't cause that problem. If you're on the capsule or oral suspension, this specific interaction with antacids isn't noted for those forms, but it's always worth mentioning all your medications to your pharmacist.

Is Cefaclor available over the counter?

▾
No. Cefaclor is a prescription medicine: every Cefaclor product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Cefaclor first available?

▾
The earliest FDA record we hold for Cefaclor is from 1979: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Cefaclor was first used.

Who makes Cefaclor?

▾
4 companies currently list Cefaclor products in the FDA's NDC Directory, including Carlsbad Technology, Inc., A-S Medication Solutions, Azorian Pharma, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Cefaclor on HelloPharmacist

📊Cefaclor supplement interactions60 checked — ranked by severity 🌿Drug & Supplement CheckerCefaclor vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Cefaclor NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Cefaclor Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Cefaclor forms and strengths (how it comes)

Cefaclor is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
How this form is used
What it may be used for
  • Cefaclor Capsule is used to treat ear infections (otitis media)
  • Cefaclor Capsule is used to treat lower respiratory tract infections, including pneumonia
  • Cefaclor Capsule is used to treat strep throat, tonsillitis, and urinary tract infections
  • Cefaclor Capsule is used to treat skin and skin structure infections
Important instructions
  • Cefaclor Capsule is taken by mouth, typically every 8 hours
  • Cefaclor Capsule may be taken with or without food
  • For strep throat infections, Cefaclor Capsule should be taken for at least 10 days
  • Cefaclor Capsule may be used in patients with reduced kidney function — follow your prescriber's guidance on dosing
Available strengths 2 strengths
250 mg 500 mg
6 FDA-listed product records ⓘ

Extended-release tablet

By mouth
How this form is used
What it may be used for
  • Cefaclor extended-release tablet is used to treat acute bacterial flare-ups of chronic bronchitis
  • Cefaclor extended-release tablet is used to treat strep throat and tonsillitis
  • Cefaclor extended-release tablet is used to treat uncomplicated skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus
Important instructions
  • Cefaclor extended-release tablet must be taken with food — within 1 hour of a meal
  • Cefaclor extended-release tablet is taken twice a day (every 12 hours)
  • Cefaclor extended-release tablet must not be cut, crushed, or chewed — swallow whole
  • Avoid taking antacids containing magnesium or aluminum hydroxide within 1 hour of a Cefaclor extended-release tablet dose
Available strengths 1 strength
500 mg
1 FDA-listed product record ⓘ

Oral suspension

By mouth
How this form is used
What it may be used for
  • Cefaclor oral suspension is used to treat ear infections (otitis media) in adults and children
  • Cefaclor oral suspension is used to treat lower respiratory tract infections including pneumonia
  • Cefaclor oral suspension is used to treat strep throat, tonsillitis, urinary tract infections, and skin infections
  • Cefaclor oral suspension is a common option for children who cannot swallow capsules
Important instructions
  • Cefaclor oral suspension is taken by mouth, typically every 8 hours; for otitis media and pharyngitis in children, dosing every 12 hours may also be used
  • Shake the bottle well before each use
  • Cefaclor oral suspension may be taken with or without food
  • For strep infections, Cefaclor oral suspension should be taken for at least 10 days
Available strengths 1 strength
250 mg/5 mL
1 FDA-listed product record ⓘ

Cefaclor on the U.S. market: products, makers and brands

How Cefaclor appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

4 companies list 5 Cefaclor product records with the FDA, mostly as capsule, extended-release tablet, oral suspension; the earliest marketing or approval year on record is 1979. Brand names on the directory include Ceclor, Ceclor CD, Raniclor; the rest are generics.

3
Dose forms ⓘ
4
Labelers (makers, repackagers, distributors)
1
Brand names
5
FDA-listed product records ⓘ
1979
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Carlsbad Technology, Inc.40%
A-S Medication Solutions20%
Azorian Pharma, LLC20%
Teva Pharmaceuticals USA, Inc.20%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Cefaclor is used (Medicaid data)

A general measure of how commonly Cefaclor is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cefaclor is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

394
Medicaid prescriptions filled (Q1–Q4 2025)
$15,556 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cefaclor prescribed? Of the 1,601 medications we measure, Cefaclor ranks #1,385 by Medicaid prescriptions — more than 13% of them.

Where Cefaclor ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,385 of 1,601
#1,380 Fostamatinib 407 Rx #1,381 Carbidopa 402 Rx #1,382 Quinine 401 Rx #1,383 Istradefylline 400 Rx #1,384 Alanine / Arginine / D... 400 Rx #1,385 Cefaclor 394 Rx #1,386 Gatifloxacin Ophthalmi... 390 Rx #1,387 Vinorelbine Injection 384 Rx #1,388 Elafibranor 383 Rx #1,389 Telavancin Injection 379 Rx #1,390 Nitazoxanide 378 Rx

Utilization by Cefaclor product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 500 mg oral capsule is the most-dispensed Cefaclor product — about 94% of these Medicaid prescriptions.

cefaclor 500 MG Oral Capsule Most dispensed

369 Medicaid prescriptions (Q1–Q4 2025) 94% of Cefaclor prescriptions shown $14,720 gross reimbursement (before rebates) ≈ $40 per prescription (gross)

Summed across the 1 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197449

cefaclor 250 MG Oral Capsule

25 Medicaid prescriptions (Q1–Q4 2025) 6% of Cefaclor prescriptions shown $836 gross reimbursement (before rebates) ≈ $33 per prescription (gross)

Summed across the 1 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309045

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cefaclor, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 44 listed Cefaclor NDCs with Medicaid activity.

Compare Cefaclor products

A representative set of FDA-listed product records for Cefaclor — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
500 mg Oral A-S Medication Solutions ANDA View NDC →
250 mg Oral Carlsbad Technology, Inc. ANDA View NDC →
500 mg Oral Carlsbad Technology, Inc. ANDA View NDC →
💊Extended-release tablet
500 mg Oral Teva Pharmaceuticals USA, Inc. ANDA View NDC →
💊Oral suspension
250 mg/5 mL Oral Azorian Pharma, LLC ANDA View NDC →

Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Cefaclor NDCs →

Cefaclor recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Cefaclor recalls since July 2021.

✅No Cefaclor recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Cefaclor RxCUI 2176 4 dose forms · 11 strengths
  1. Dose form (SCDF) Chewable Tablet RxCUI 476324 No current FDA listing
    Clinical drug / strength (SCD) 125 MG RxCUI 476322 187 MG RxCUI 476325 250 MG RxCUI 476327 375 MG RxCUI 476623
  2. Dose form (SCDF) Extended Release Oral Tablet RxCUI 378228 In current FDA listings
    Clinical drug / strength (SCD) 12 HR cefaclor 500 MG RxCUI 309043
  3. Dose form (SCDF) Oral Capsule RxCUI 371313 In current FDA listings
    Clinical drug / strength (SCD) 250 MG RxCUI 309045 500 MG RxCUI 197449
  4. Dose form (SCDF) Oral Suspension RxCUI 371314 In current FDA listings
    Clinical drug / strength (SCD) 25 MG/ML RxCUI 309044 37.4 MG/ML RxCUI 309040 50 MG/ML RxCUI 313888 75 MG/ML RxCUI 309042

Look up RxCUI 2176 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Cefaclor costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 250 mg $0.932 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Cefaclor brand names

Cefaclor is sold under 3 brand names in the FDA directory — Ceclor, Ceclor CD, Raniclor. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Ceclor Ceclor CD Raniclor

Who makes Cefaclor: manufacturers and labelers

4 companies list Cefaclor products with the FDA. By number of product records, the largest are Carlsbad Technology, Inc., A-S Medication Solutions, Azorian Pharma, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Carlsbad Technology, Inc. 2 A-S Medication Solutions 1 Azorian Pharma, LLC 1 Teva Pharmaceuticals USA, Inc. 1

Cefaclor drug class (RxNorm)

Cefaclor belongs to the Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial
Drug family (ATC) Second-generation cephalosporins

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Cefaclor page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 31, 2019
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cefaclor.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cefaclor after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
Finished products in the current FDA directory
5
Companies listing them (makers, repackagers, distributors)
4
FDA labeler codes behind them ⓘ
4
Linked representative label ⓘ
Teva Pharmaceuticals USA, Inc.
Linked label effective
Jul 31, 2019
Composite sections available
18
Linked SPL Set ID
0878bdc2-0410-4938-9890-96523aa81c2f
Linked SPL Document ID
61ec00e0-d37d-4aa4-8f50-031ee7a37ecc
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Teva Pharmaceuticals USA, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →