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Cephalexin 500 mg Tablet, 100-count — NDC 00093-2240-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cephalexin 500 mg Tablet, 100-count — NDC 0093-2240-01 (Billing 00093-2240-01)

by Teva Pharmaceuticals USA, Inc. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Cephalexin 500 mg Tablet from Teva Pharmaceuticals USA, Inc., marketed since Sep 1990 and currently FDA-listed; retail pharmacies pay about $1.27 per tablet (NADAC). It is this product's only package size.

NDC 00093-2240-01
🏷️ FDA NDC (as labeled) 0093-2240-01 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Cephalexin (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 23, 2025 — Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. (Ascend Laboratories, LLC) · FDA recall D-0469-2025
Class II · May 23, 2025 — Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. (Ascend Laboratories, LLC) · FDA recall D-0468-2025
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g (Bryant Ranch Prepack, Inc.) · FDA recall D-0537-2024
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g' (Bryant Ranch Prepack, Inc.) · FDA recall D-0539-2024
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' (Bryant Ranch Prepack, Inc.) · FDA recall D-0538-2024
Class III · May 10, 2024 — Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' (Bryant Ranch Prepack, Inc.) · FDA recall D-0540-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0093-2240-01
Product NDC 0093-2240
11-digit billing NDC 00093224001
NCPDP billing unit EA — each (per item)
RxCUI 197454, 309115
UNII OBN7UDS42Y
Application # ANDA063024
SPL Set ID 445b2a87-2e4f-483a-abe8-26fefd67514a
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-09-30
Route ORAL
Dosage form TABLET
Substance CEPHALEXIN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 02100020000315
GPI class Cephalexin
GCN Seq No 009049
GCN 39831
HICL code 013908
Ingredient (HICL) Cephalexin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1W
Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 1St Generation
AHFS code 08:12.06.04
AHFS class 1St Generation Cephalosporin Antibiotics
FDB label name CEPHALEXIN 500 MG TABLET
FDB brand name Cephalexin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009049
  • GCN: 39831
  • GPI-14 (Medi-Span): 02100020000315
  • HICL (First Databank): 013908
  • AHFS class code: 08:12.06.04
  • RxCUI (RxNorm): 197454
Why two NDCs? The FDA registers this code as 0093-2240-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00093-2240-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial
Drug family (ATC) First-generation cephalosporins
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CEPHALEXIN 500 MG TABLET Ingredient Cephalexin
📖 What it is MedlinePlus · NLM

Cephalexin is used to treat certain infections caused by bacteria. Cephalexin is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics such as cephalexin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Cephalexin is an antibiotic used to treat bacterial infections — things like strep throat and other respiratory infections, ear infections, skin infections, bone infections, and ur...
  • Yes, you can take cephalexin with or without food — it's stable in stomach acid either way. If it upsets your stomach, taking it with a small meal or snack can help. Just try to ta...
  • The most common side effects are stomach-related — diarrhea, nausea, vomiting, or indigestion. These are usually mild and manageable. The ones to call your doctor about are: a seve...
  • What side effects should I watch out for?
📖 Read our full Cephalexin guide →
7
Nutrient depletion considerations

Cephalexin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $1.265 $126.54 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $2.38 $237.73 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $2.24 $224.12 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jul 2022 Jan 2024 Apr 2026 Sep 2026 $1.998 $1.265
▼ Down 35% over the last 15 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00093-2240-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 1990-09-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cephalexin 500 mgthis 00093-2240-01 Teva 100 tablets $1.265 AB Availability likely —
Cephalexin 500 mg 59651-0784-01 Aurobindo 100 tablets $1.265 AB Availability likely —
Cephalexin 500 mg 67877-0892-01 Ascend 100 tablets $1.265 AB Availability likely —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeOval
Imprint22;40;TEVA
Size16 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerTeva Pharmaceuticals USA, Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA063024 (ANDA)
Labeler code00093
First marketedSep 1990
Product typeHuman Prescription Drug
Portfolio504 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 183 words ▾

INDICATIONS AND USAGE Cephalexin tablets are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes Otitis media due to susceptible isolates of Streptococcu pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes , and Moraxella Catarrhalis. Skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus , and Streptococcus pyogenes .

Bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus Mirabilis. Genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniare. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin tablets and other antibacterial drugs, cephalexin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Cephalexin tablets are administered orally. Adults and Pediatric Patients at Least 15 Years of Age The usual dose is 250 mg every 6 hours but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days.

For more severe infections larger doses of oral cephalexin may be needed, up to 4 grams in two to four equally divided doses. Pediatric Patients (over 1 year of age) The recommended total daily dose of oral cephalexin for pediatric patients is 25 to 50 mg/kg in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended.

In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses. In the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg/day in equally divided doses. Dosage adjustments in Adults and Pediatric Patients at Least 15 years of Age with Renal Impairment Administer the following dosing regimens for cephalexin tablets to patients with renal impairment (see PRECAUTIONS ).

Table 1. Recommended Dose Regimen for Patients with Renal Impairment Renal function Dose regimen recommendation Creatinine clearance ˃60 mL/min No dose adjustment Creatinine clearance 30 to 59 mL/min No dose adjustment; maximum daily dose should not exceed 1 g Creatinine clearance 15 to 29 mL/min 250 mg, every 8 hours or every 12 hours Creatinine clearance 5 to 14 mL/min not yet on dialysis* 250 mg, every 24 hours Creatinine clearance 1 to 4 mL/min not yet on dialysis* 250 mg, every 48 hours or every 60 hours *There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Cephalexin tablets are contraindicated in patients with known allergy to cephalexin or other members of the cephalosporin class of antibacterial drugs.

⚠️ Warnings ~2 min read ▾

WARNINGS Hypersensitivity Reactions Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of cephalexin tablets. Before therapy with cephalexin tablets is instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy.

If an allergic reaction to cephalexin tablets occurs, discontinue the drug and institute appropriate treatment. Clostridium difficile-Associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cephalexin tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

Direct Coomb’s Test Seroconversion Positive direct Coombs tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. Acute intravascular hemolysis induced by cephalexin therapy has been reported. If anemia develops during or after cephalexin therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute appropriate therapy.

Seizure Potential Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue cephalexin tablets. Anticonvulsant therapy can be given if clinically indicated.

Prolonged Prothrombin Time Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated.

🤒 Adverse Reactions 204 words ▾

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred.

As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported. Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported.

Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (ALT) have been reported. In addition to the adverse reactions listed above that have been observed in patients treated with cephalexin tablets, the following adverse reactions and other altered laboratory tests have been reported for cephalosporin class antibacterial drugs: Other Adverse Reactions : Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy.

Altered Laboratory Tests : Prolonged prothrombin time, increased blood urea nitrogen (BUN), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.

🔄 Drug Interactions 87 words ▾

Drug Interactions Metformin: Administration of cephalexin tablets with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin tablets and metformin (see CLINICAL PHARMACOLOGY ). Probenecid: The renal excretion of cephalexin tablets is inhibited by probenecid.

Coadministration of probenecid with cephalexin tablets is not recommended. Drug/laboratory Test Interactions: A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict's solution or Fehling's solutions.

🤰 Pregnancy 79 words ▾

Pregnancy Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon body surface area basis and have revealed no evidence of impaired fertility or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 32 words ▾

Pediatric Use The safety and effectiveness of cephalexin tablets in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section (see DOSAGE AND ADMINISTRATION ).

🧓 Geriatric Use 95 words ▾

Geriatric Use Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection.

🆘 Overdosage 43 words ▾

OVERDOSAGE Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Human Pharmacology Cephalexin tablets are acid stable and may be given without regard to meals. It is rapidly absorbed after oral administration. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL, respectively, were obtained at 1 hour.

Serum levels were detectable 6 hours after administration (at a level of detection of 0.2 mcg/mL). Cephalexin is approximately 10% to 15% bound to plasma proteins. Cephalexin is excreted in the urine by glomerular filtration and tubular secretion.

Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations following the 250 mg, 500 mg, and 1 g doses were approximately 1,000, 2,200, and 5,000 mcg/mL, respectively. In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean C max and AUC increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%.

No information is available about the interaction of cephalexin and metformin following multiple doses of either drug. Microbiology Cephalexin is a bactericidal agent that acts by the inhibition of cell-wall synthesis. Resistance Methicillin-resistant staphylococci and most isolates of enterococci are resistant to cephalexin.

Cephalexin is not active against most isolates of Enterobacter spp. , Morganella morganii , and Proteus vulqaris . Cephalexin has no activity against Pseudomonas spp. , or Acinetobacter calcoaceticus . Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibacterial drugs.

Antimicrobial Activity Cephalexin is active against most isolates of the following bacteria both in vitro and in clinical infections (see INDICATIONS AND USAGE ): Gram-positive bacteria Staphylococci aureus (methicillin-susceptible isolates only) Streptococcus pneumoniae (penicillin-susceptible isolates) Streptococcus pyogenes Gram-negative bacteria Escherichia coli Haemophilus influenzae Klebsiella pneumoniae Moraxella catarrhalis Proteus mirabilis Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

📦 How Supplied / Storage and Handling 133 words ▾

HOW SUPPLIED Cephalexin tablets, USP are supplied as follows: 250 mg: bottles of 100 (NDC 0093-2238-01). Tablet identification number and color: white, capsule-shaped tablet, debossed “2238” on one side with a score between the “2” and the “3” and “TEVA” on the reverse side. 500 mg: bottles of 100 (NDC 0093-2240-01).

Tablet identification number and color: white, capsule-shaped tablet, debossed “2240” on one side with a score between the “2” and the “4” and “TEVA” on the reverse side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep tightly closed. Keep this and all medications out of the reach of children. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.

B 10/2023

📋 Description ~1 min read ▾

DESCRIPTION Cephalexin tablets, USP contain the active ingredient cephalexin, which is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α- amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the molecular formula C 16 H 17 N 3 O 4 S•H 2 O and the molecular weight is 365.40.

Cephalexin, USP has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.

The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.

The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D -phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each tablet contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin.

The tablets also contain magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 250 mg contains hypromellose and polysorbate 80. The 500 mg contains polyvinyl alcohol-part hydrolyzed and talc. cephalexin structural formula

💬 Information for Patients 216 words ▾

Information for Patients Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin tablets, other beta-lactams (including cephalosporins) or other allergens (see WARNINGS ) . Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Patients should be counseled that antibacterial drugs including cephalexin tablets should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When cephalexin tablets is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cephalexin tablets or other antibacterial drugs in the future.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Prescribing cephalexin tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Prolonged use of cephalexin tablets may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential.

If superinfection occurs during therapy, appropriate measures should be taken. Information for Patients Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin tablets, other beta-lactams (including cephalosporins) or other allergens (see WARNINGS ) .

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Patients should be counseled that antibacterial drugs including cephalexin tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin tablets is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cephalexin tablets or other antibacterial drugs in the future. Drug Interactions Metformin: Administration of cephalexin tablets with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin tablets and metformin (see CLINICAL PHARMACOLOGY ).

Probenecid: The renal excretion of cephalexin tablets is inhibited by probenecid. Coadministration of probenecid with cephalexin tablets is not recommended. Drug/laboratory Test Interactions: A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict's solution or Fehling's solutions.

Pregnancy Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon body surface area basis and have revealed no evidence of impaired fertility or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers Cephalexin is excreted in human milk. Caution should be exercised when cephalexin tablets are administered to a nursing woman. Pediatric Use The safety and effectiveness of cephalexin tablets in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section (see DOSAGE AND ADMINISTRATION ).

Geriatric Use Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because eld… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 21 words ▾

Nursing Mothers Cephalexin is excreted in human milk. Caution should be exercised when cephalexin tablets are administered to a nursing woman.

📄 Package Label / Principal Display Panel 32 words ▾

Package/Label Display Panel NDC 0093-2238-01 Cephalexin Tablets, USP 250 mg Rx only 100 Tablets 250 mg

Package/Label Display Panel NDC 0093-2240-01 Cephalexin Tablets, USP 500 mg Rx only 100 Tablets 500 mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
32.8K
Units reimbursed last 4 qtrs
703.5K
Gross reimbursed last 4 qtrs
$1.67M
Avg / prescription
$50.96
Avg / unit
$2.3773
Latest quarter Q1 2026
5.6KRx
Medicaid pays / ea
$2.3773
gross reimbursed
vs
NADAC / ea
$1.2654
acquisition cost
=
Spread
+$1.1119
+88% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
45% FFS 55% MCO
Fee-for-service · 14,928 Rx Managed care · 17,891 Rx
State Medicaid map
Alaska: 700 units · 95.5 per 100k residents AK Maine: no data reported ME Washington: 297 units · 3.8 per 100k residents WA Idaho: 1,260 units · 64.2 per 100k residents ID Montana: 1,437 units · 127 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 47,240 units · 471 per 100k residents MI New York: 225,110 units · 1,150 per 100k residents NY Vermont: no data reported VT New Hampshire: 2,473 units · 176 per 100k residents NH Oregon: 2,422 units · 57.2 per 100k residents OR Nevada: 12,317 units · 386 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 242 units · 7.5 per 100k residents IA Illinois: 49,730 units · 396 per 100k residents IL Indiana: 35,627 units · 519 per 100k residents IN Ohio: 1,856 units · 15.7 per 100k residents OH Pennsylvania: 6,093 units · 47.0 per 100k residents PA New Jersey: 16,626 units · 179 per 100k residents NJ Massachusetts: 42,358 units · 605 per 100k residents MA California: 18,670 units · 47.9 per 100k residents CA Utah: 330 units · 9.7 per 100k residents UT Colorado: 8,397 units · 143 per 100k residents CO Nebraska: no data reported NE Missouri: 693 units · 11.2 per 100k residents MO Kentucky: 1,214 units · 26.8 per 100k residents KY West Virginia: no data reported WV Virginia: 20,146 units · 231 per 100k residents VA Maryland: 37,398 units · 605 per 100k residents MD Connecticut: 15,735 units · 435 per 100k residents CT Rhode Island: no data reported RI Arizona: 39,602 units · 533 per 100k residents AZ New Mexico: no data reported NM Kansas: 4,154 units · 141 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 27,469 units · 254 per 100k residents NC South Carolina: 17,801 units · 331 per 100k residents SC Delaware: 283 units · 27.4 per 100k residents DE Oklahoma: 895 units · 22.1 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 14,749 units · 289 per 100k residents AL Georgia: 8,905 units · 80.7 per 100k residents GA D.C.: 214 units · 31.5 per 100k residents DC Hawaii: 10,277 units · 716 per 100k residents HI Texas: 23,729 units · 77.8 per 100k residents TX Florida: 7,062 units · 31.2 per 100k residents FL
Units reimbursed · per 100k residents
3.81,150
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 1,150 /100k
2 Hawaii 716 /100k
3 Maryland 605 /100k
4 Massachusetts 605 /100k
5 Arizona 533 /100k
6 Indiana 519 /100k
7 Michigan 471 /100k
8 Connecticut 435 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cephalexin — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cephalexin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$13.31M
Claims incl. refills
1.8M
Beneficiaries
1.6M
Spend / beneficiary
$8.47
Spend / claim
$7.30
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.