What this pack is
KEFLEX is the brand name in this record; cephalexin is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
KEFLEXGeneric namecephalexin
How this medicine works
The current FDA label explains that cephalexin is bactericidal through inhibition of bacterial cell-wall synthesis. The mechanism only helps explain the class; fever, cough, sore throat, urinary or skin symptoms alone cannot establish a bacterial cause, susceptibility, whether it should be used or for how long.
Read source: United States ↗Current regulatory record · reviewed 2026-08-28More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- KEFLEX
- Generic name
- cephalexin
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
4 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)
Equivalent to cephalexin 250 mg per capsule; 100-capsule bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 58463-011-01
- Form and route
- KEFLEX cephalexin oral capsule · oral (exact capsule-product identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- cephalexin (supplied as cephalexin monohydrate)
- 250 mglabelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- white and dark green · capsule; unscored · imprint KEFLEX / 250 mgUnscored in this labelled presentation
United States label · Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)
Equivalent to cephalexin 500 mg per capsule; 100-capsule bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 58463-012-01
- Form and route
- KEFLEX cephalexin oral capsule · oral (exact capsule-product identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- cephalexin (supplied as cephalexin monohydrate)
- 500 mglabelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- light green and dark green · capsule; unscored · imprint KEFLEX / 500 mgUnscored in this labelled presentation
United States label · Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)
Equivalent to cephalexin 750 mg per capsule; 50-capsule bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 58463-013-50
- Form and route
- KEFLEX cephalexin oral capsule · oral (exact capsule-product identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- cephalexin (supplied as cephalexin monohydrate)
- 750 mglabelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction
- Package
- 50 capsules per bottle
- Labelled appearance
- dark green · capsule; unscored · imprint KEFLEX / 750 mgUnscored in this labelled presentation
United States label · Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)
Equivalent to cephalexin 750 mg per capsule; 20-capsule bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 58463-013-20
- Form and route
- KEFLEX cephalexin oral capsule · oral (exact capsule-product identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-28; actual marketing, stock and availability are not established.
- cephalexin (supplied as cephalexin monohydrate)
- 750 mglabelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction
- Package
- 20 capsules per bottle
- Labelled appearance
- dark green · capsule; unscored · imprint KEFLEX / 750 mgUnscored in this labelled presentation
PACKAGE-VISUAL STATUS
Current label text verifies colour, imprint, strength, NDC and pack count, but text-only identity is not presented as an official package image
The 2026 FDA label provides appearance text for 250, 500 and 750 mg capsules and four bottle NDCs, but this review did not obtain an official principal display panel safely matched one-to-one to each current pack. The page therefore shows source-traceable text identity and an enlarged label, without substituting retail, repackaged or historical imagery for a current KEFLEX pack.
LABEL READING · NOT A PRESCRIPTION
KEFLEX label reading: separate mg per capsule, the capsule form and the prescribed schedule
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The current 2026 FDA label separately lists 250, 500 and 750 mg oral capsules. This module helps ordinary readers check the exact product, allergy and serious-diarrhoea warnings, kidney function and interaction questions; it gives no individual capsule count, interval or course.
- 250, 500 and 750 mg are the labelled cephalexin amounts per capsule, not capsules per dose or doses per day. Do not self-substitute several smaller capsules for a larger one, open and halve a capsule, make up a dose or assemble a course from a total milligram number.
- Tell the prescriber about previous reactions to cephalosporins, penicillins or other medicines. Breathing difficulty, facial or throat swelling, widespread rash, fainting or another severe allergic feature requires immediate local emergency care.
- Severe, persistent or bloody diarrhoea, marked abdominal pain, fever, dehydration or weakness may require prompt medical assessment; the label explains that this problem can appear after antibacterial treatment has ended. Do not self-use an antidiarrhoeal medicine to mask severe symptoms.
- Older adults or people with impaired kidney function especially need professional review of kidney function and the prescription. The label also notes metformin, probenecid and some urine-glucose testing. The site does not change individual use from age, a laboratory value or a medicine name.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkFDA · United States · Regulatory product record or label archive · 2026-08-28
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 1
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeFDA: current U.S. KEFLEX (cephalexin) oral-capsule prescribing information (NDA 050405; revised Aug 2026) ↗Current regulatory record · reviewed 2026-08-28
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about KEFLEX (cephalexin). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
KEFLEX is the brand in this record and cephalexin is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
HOW IT WORKS · NOT A TREATMENT PLAN
How cephalexin works: inhibiting bacterial cell-wall synthesis does not mean it treats every infection
- Antibacterials do not treat an ordinary viral cold. Do not use leftovers, share, self-start because symptoms seem similar or shorten a prescribed course because you feel better.
- A cephalosporin class or infection-related use does not make KEFLEX self-switchable, alternatable or combinable with amoxicillin, amoxicillin/clavulanate, azithromycin, clindamycin or levofloxacin.
- The organism, culture or susceptibility result, infection site, allergy history, kidney function, age and complete medicine list can all affect professional judgement. The site helps read the label and does not select an antibacterial for an individual.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- FDA: current U.S. KEFLEX (cephalexin) oral-capsule prescribing information (NDA 050405; revised Aug 2026) ↗Current regulatory record · reviewed 2026-08-28
- FDA Drugs@FDA: current KEFLEX (cephalexin) NDA 050405 application and label record ↗Current regulatory record · reviewed 2026-08-28
SOURCE-TRACEABLE ARCHIVE
KEFLEXcephalexin
This page links to public primary-source material for KEFLEX. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year
The current FDA label states Initial U.S. Approval: 1971. This records the year only and does not infer the first pack, another market's status or current supply.
FDA: current U.S. KEFLEX (cephalexin) oral-capsule prescribing information (NDA 050405; revised Aug 2026) ↗FDA approved the SUPPL-106 label update
The FDA approval letter links KEFLEX 250, 500 and 750 mg capsules to NDA 050405. This node checks application history and does not replace the current label.
FDA: KEFLEX NDA 050405/S-106 supplemental approval letter (2015) ↗FDA posted the current SUPPL-111 label
The current Drugs@FDA application page lists the SUPPL-111 label on 3 Aug 2026, with prescribing information revised Aug 2026. The date identifies the file version, not anyone's start date, course or a stock conclusion.
FDA Drugs@FDA: current KEFLEX (cephalexin) NDA 050405 application and label record ↗
MARKET SCOPE
Market-record boundary
United States
Current FDA application record, oral-capsule label and four exact text package identities linkedThe dossier records NDC, bottle count, colour and imprint for 250, 500 and 750 mg capsules. A label does not establish local stock, purchase availability, individual suitability or self-switching between strengths.
Mainland China, EU, Japan and other markets
Current market record not establishedNo local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. brand, NDA, generic name or capsule appearance.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Does 500 mg on the pack mean one capsule per dose?
No. 500 mg is the labelled amount in each exact capsule. Individual capsule count, frequency, course and suitability must come from the exact prescription and professional review of infection type, allergy history, kidney function, age and the complete medicine list.
If the capsule is too large, can it be opened, halved or mixed into food?
Do not do this yourself. This page verifies an intact oral capsule and has no evidence that visual halving or mixing with food is an equal, stable and individually suitable alternative. Before changing it, ask a pharmacist or prescriber to check the exact product, available form and prescription.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.