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Cephalexin 500 mg Capsule, 20-count — NDC 80425-0121-04 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 Capsule, 20-count — NDC 80425-0121-4 (Billing 80425-0121-04)

by Advanced Rx Pharmacy of Tennessee, LLC · 20 CAPSULE in 1 BOTTLE

This is a package of 20 capsules of Cephalexin 500 mg Capsule from Advanced Rx Pharmacy of Tennessee, LLC, marketed since Jan 2011 and currently FDA-listed.

NDC 80425-0121-04
🏷️ FDA NDC (as labeled) 80425-0121-4 billing pads the package segment with a zero
This package
Contains20-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.1952/unit — full pricing hub ↓
Product page 80425-0121-01 Also comes in: 5 capsules 80425-0121-6 6 capsules 80425-0121-7 14 capsules 80425-0121-5 28 capsules 80425-0121-1 30 capsules 80425-0121-3 40 capsules 80425-0121-2
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 80425-0121-4
Product NDC 80425-0121
11-digit billing NDC 80425012104
NCPDP billing unit EA — each (per item)
RxCUI 309114
UNII OBN7UDS42Y
Application # ANDA090836
SPL Set ID b6ffe633-dd91-6d49-e053-2a95a90a5ac6
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 2011-01-19
Route ORAL
Dosage form CAPSULE
Substance CEPHALEXIN
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 309114
Why two NDCs? The FDA registers this code as 80425-0121-4 — a 5-4-1 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 package segment → 80425-0121-04. 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

📗 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.

🧪 Full Cephalexin nutrient depletion report →
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1952 $3.90 / 20 capsules
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
80425-0121-01 80425-0121-1 Main listing 28 CAPSULE in 1 BOTTLE 2011-01-19 — Active
80425-0121-02 80425-0121-2 40 CAPSULE in 1 BOTTLE 2011-01-19 — Active
80425-0121-03 80425-0121-3 30 CAPSULE in 1 BOTTLE 2011-01-19 — Active
80425-0121-04 You're viewing this 20 CAPSULE in 1 BOTTLE 2011-01-19 — Active
80425-0121-05 80425-0121-5 14 CAPSULE in 1 BOTTLE 2011-01-19 — Active
80425-0121-06 80425-0121-6 5 CAPSULE in 1 BOTTLE 2023-09-15 — Active
80425-0121-07 80425-0121-7 6 CAPSULE in 1 BOTTLE 2024-01-17 — Active

You're viewing one of 7 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 20-count package — 20 capsule in 1 bottle.
How does this package differ from NDC 80425-0121-06?
Both are Cephalexin 500 mg Capsule — the drug itself is identical. This page's package is the 20-count one, while NDC 80425-0121-06 is the 5 capsules package.
What NDC number is used to bill for this package of Cephalexin 500 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cephalexin 500 mg 00093-3147-01 Teva 100 capsules $0.120 AB Discontinued —
Cephalexin 500 mg 00904-7337-06 Major 50 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 50268-0152-15 AvPAK 50 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 60687-0163-01 American 100 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 62135-0711-74 Chartwell 40 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 65862-0019-01 Aurobindo 100 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 67877-0219-01 Ascend 100 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 68180-0122-01 Lupin 100 capsules $0.120 AB Availability likely —
Cephalexin 500 mg 42291-0007-50 AVKARE 500 capsules — AB FDA listed —
Cephalexin 500 mg 42708-0017-28 QPharma 28 capsules — AB FDA listed —
Cephalexin 500 mg 42708-0070-28 QPharma 28 capsules — AB FDA listed —
Cephalexin 500 mg 43063-0536-04 PD-Rx 4 capsules — AB FDA listed —
Cephalexin 500 mg 43063-0634-40 PD-Rx 40 capsules — AB FDA listed —
Cephalexin 500 mg 50090-0079-00 A-S 20 capsules — AB FDA listed —
Cephalexin 500 mg 50090-0080-01 A-S 12 capsules — AB FDA listed —
Cephalexin 500 mg 50090-0081-00 A-S 40 capsules — AB FDA listed —
Cephalexin 500 mg 50090-3199-00 A-S 20 capsules — AB FDA listed —
Cephalexin 500 mg 50090-3252-00 A-S 40 capsules — AB FDA listed —
Cephalexin 500 mg 50090-3427-01 A-S 12 capsules — AB FDA listed —
Cephalexin 500 mg 50090-4422-00 A-S 20 capsules — AB FDA listed —
Cephalexin 500 mg 50090-5948-00 A-S 20 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7026-01 A-S 12 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7027-00 A-S 100 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7162-01 A-S 28 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7223-00 A-S 100 capsules — AB FDA listed —
Cephalexin 500 mg 50090-7224-00 A-S 100 capsules — AB FDA listed —
Cephalexin 500 mg 51655-0028-20 Northwind 20 capsules — AB Discontinued —
Cephalexin 500 mg 55289-0058-04 PD-Rx 4 capsules — AB FDA listed —
Cephalexin 500 mg 61919-0606-20 Direct_Rx 20 capsules — AB FDA listed —
Cephalexin 500 mg 63187-0046-06 Proficient 6 capsules — AB FDA listed —
Cephalexin 500 mg 63629-4219-01 Bryant 40 capsules — AB FDA listed —
Cephalexin 500 mg 63629-5740-01 Bryant 20 capsules — AB FDA listed —
Cephalexin 500 mg 63629-5741-01 Bryant 28 capsules — AB FDA listed —
Cephalexin 500 mg 63629-5742-01 Bryant 30 capsules — AB FDA listed —
Cephalexin 500 mg 63629-7740-01 Bryant 28 capsules — AB FDA listed —
Cephalexin 500 mg 63629-7742-01 Bryant 20 capsules — AB FDA listed —
Cephalexin 500 mg 63629-7743-01 Bryant 14 capsules — AB FDA listed —
Cephalexin 500 mg 63629-8184-01 Bryant 12 capsules — AB FDA listed —
Cephalexin 500 mg 63629-8856-01 Bryant 500 capsules — AB FDA listed —
Cephalexin 500 mg 63629-9200-01 Bryant 100 capsules — AB FDA listed —
Cephalexin 500 mg 63629-9201-01 Bryant 500 capsules — AB FDA listed —
Cephalexin 500 mg 67046-1245-03 Coupler 30 capsules — AB FDA listed —
Cephalexin 500 mg 68071-2249-03 NuCare 30 capsules — AB FDA listed —
Cephalexin 500 mg 68071-3532-01 NuCare 21 capsules — AB FDA listed —
Cephalexin 500 mg 68071-3538-06 NuCare 6 capsules — AB FDA listed —
Cephalexin 500 mg 68071-4355-01 NuCare 21 capsules — AB FDA listed —
Cephalexin 500 mg 68071-4406-04 NuCare 14 capsules — AB FDA listed —
Cephalexin 500 mg 68071-4429-03 NuCare 3 capsules — AB FDA listed —
Cephalexin 500 mg 68788-8538-01 Preferred 12 capsules — AB FDA listed —
Cephalexin 500 mg 68788-8740-01 Preferred 12 capsules — AB FDA listed —
Cephalexin 500 mg 69043-0009-01 Cronus 100 capsules — AB FDA listed —
Cephalexin 500 mg 69778-0931-04 Pharma-C, 500 capsules — AB FDA listed —
Cephalexin 500 mg 70518-3059-00 REMEDYREPACK 14 capsules — AB FDA listed —
Cephalexin 500 mg 70518-3066-00 REMEDYREPACK 30 capsules — AB Discontinued —
Cephalexin 500 mg 70518-3362-00 REMEDYREPACK 30 capsules — AB FDA listed —
Cephalexin 500 mg 70518-3378-00 REMEDYREPACK 40 capsules — AB FDA listed —
Cephalexin 500 mg 70518-3448-00 REMEDYREPACK 100 capsules — AB Discontinued —
Cephalexin 500 mg 70518-3857-00 REMEDYREPACK 42 capsules — AB Discontinued —
Cephalexin 500 mg 71205-0591-06 Proficient 6 capsules — AB FDA listed —
Cephalexin 500 mg 71205-0672-06 Proficient 6 capsules — AB FDA listed —
Cephalexin 500 mg 71335-2685-01 Bryant 14 capsules — AB FDA listed —
Cephalexin 500 mg 71335-2704-01 Bryant 21 capsules — AB FDA listed —
Cephalexin 500 mg 71335-2976-01 Bryant 12 capsules — AB FDA listed —
Cephalexin 500 mg 72162-1830-01 Bryant 100 capsules — AB FDA listed —
Cephalexin 500 mg 72162-2145-05 Bryant 500 capsules — AB FDA listed —
Cephalexin 500 mg 72287-0310-01 AMELLA 100 capsules — AB FDA listed —
Cephalexin 500 mg 72789-0251-82 PD-Rx 500 capsules — AB FDA listed —
Cephalexin 500 mg 73614-0202-03 Brisk 30 capsules — AB Discontinued —
Cephalexin 500 mg 76420-0052-28 Asclemed 28 capsules — AB FDA listed —
Cephalexin 500 mg 76420-0288-01 Asclemed 100 capsules — AB FDA listed —
Cephalexin 500 mg 76420-0592-10 Asclemed 100 capsules — AB FDA listed —
Cephalexin 500 mg 76420-0736-00 Asclemed 100 capsules — AB FDA listed —
Cephalexin 500 mg 76420-0831-10 Asclemed 10 capsules — AB FDA listed —
Cephalexin 500 mg 80425-0004-01 ADVANCED 28 capsules — AB FDA listed —
Cephalexin 500 mg 80425-0005-01 ADVANCED 28 capsules — AB FDA listed —
Cephalexin 500 mg 80425-0006-01 ADVANCED 28 capsules — AB FDA listed —
Cephalexin 500 mgthis 80425-0121-04 Advanced 20 capsules — AB FDA listed —
Cephalexin 500 mg 82804-0106-14 Proficient 14 capsules — AB FDA listed —
Cephalexin 500 mg 82868-0057-10 Northwind 10 capsules — AB FDA listed —
Cephalexin 500 mg 82868-0095-10 Northwind 10 capsules — AB FDA listed —
Cephalexin 500 mg 82982-0024-20 Pharmasource 20 capsules — AB Discontinued —
Cephalexin 500 mg 85766-0004-14 Sportpharm 14 capsules — AB FDA listed —
Cephalexin 500 mg 85766-0191-14 Sportpharm 14 capsules — AB FDA listed —
Cephalexin 500 mg 87441-0004-01 Unit 30 capsules — AB FDA listed —
Cephalexin 500 mg 85534-0078-00 HAWAII 1 capsule — AB FDA listed —
Cephalexin 500 mg 42291-0209-50 AvKARE 500 capsules — AB FDA listed —
Cephalexin 500 mg 68788-4143-01 Preferred 12 capsules — AB FDA listed —
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

🏛️
2011
On the market since
Jan 2011
📍
2026
Currently FDA-listed
15 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 green
ShapeCapsule
Imprint219
Size22 mm
ScoringNot scored
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAdvanced Rx Pharmacy of Tennessee, LLC
Application holderALKEM LABORATORIES LTD
FDA applicationANDA090836 (ANDA)
Labeler code80425
First marketedJan 2011
Product typeHuman Prescription Drug
Portfolio254 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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 220 words ▾

1. Indications and Usage Section 1 INDICATIONS & USAGE

1.1Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.

1.2Otitis Media Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.

1.3Skin and Skin Structure Infections Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.

1.4Bone Infections Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.

1.5Genitourinary Tract Infections Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.

1.6Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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 ▾

2. Dosage and Administration Section 2 DOSAGE & ADMINISTRATION

2.1Adults and Pediatric Patients at Least 15 Years of Age The usual dose of oral Cephalexin capsule, USP 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 capsules, USP may be needed, up to 4 grams daily in two to four equally divided doses.

2.2Pediatric Patients (over 1 year of age) The recommended total daily dose of oral Cephalexin capsules, USP for pediatric patients is 25 to 50 mg/kg given 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.

For the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in equally divided doses.

2.3Dosage Adjustments in Adult and Pediatric Patients at Least 15 Years of Age with Renal Impairment Administer the following dosing regimens for Cephalexin capsules, USP to patients with renal impairment [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6 )]. Table 1. Recommended Dose Regimen for Patients with Renal Impairment Renal function Dose regimen recommendation Creatinine clearance >60mL/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.

💊 Dosage Forms and Strengths 148 words ▾

3. Dosage Forms and Strengths 250 mg capsules: a white to off white powder filled into size 2 capsules (dark green cap and dark green body) that are imprinted with “220” on the both cap and body in edible black ink. 500 mg capsules: a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink.

333 mg capsules: a white to off white powder filled into size 1 capsules (light green cap and light green body) that are imprinted “CEP” on cap and “333” on body in edible black ink. 750 mg capsules: a white to off white powder filled into size '00 Elongated' capsules (dark green cap and dark green body) that are imprinted “CEP” on cap and “750” on body in edible white ink.

⛔ Contraindications 22 words ▾

4. Contraindications Cephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.

⚠️ Warnings and Cautions ~2 min read ▾

5. Warnings and Precautions

5.1Hypersensitivity 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. Before therapy with cephalexin 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 occurs, discontinue the drug and institute appropriate treatment.

5.2Clostridium difficile-Associated Diarrhea Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cephalexin, 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.

5.3Direct Coombs’ 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.

5.4Seizure 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. Anticonvulsant therapy can be given if clinically indicated.

5.5Prolonged 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.

5.6Development of Drug-Resistant Bacteria Prescribing cephalexin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Prolonged use of cephalexin 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.

🤒 Adverse Reactions ~1 min read ▾

6. Adverse Reactions The following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity reactions [see Warning and Precautions (5.1 )] Clostridium difficile-associated diarrhea [see Warnings and Precautions (5.2 )] Direct Coombs’ Test Seroconversion [see Warnings and Precautions (5.3 )] Seizure Potential [see Warnings and Precautions (5.4 )] Effect on Prothrombin Activity [see Warnings and Precautions (5.5 )] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.6 )]

6.1Clinical Trials Experience 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 In clinical trials, 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, 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 90 words ▾

7. Drug Interactions

7.1Metformin Administration of cephalexin 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 and metformin [see Clinical Pharmacology (12.3)]

7.2Probenecid The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended.

7.3Interaction with Laboratory or Diagnostic Testing A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict’s solution or Fehling’s solution.

👥 Use in Specific Populations ~3 min read ▾

8. Use in Specific Populations

8.1Pregnancy Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including cephalexin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-times the maximum recommended human dose (MRHD) based on body surface area during organogenesis revealed no evidence of harm to the fetus (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data While available studies cannot definitively establish the absence of risk, published data from epidemiologic studies and postmarketing case reports over several decades have not identified a consistent association with cephalosporin use, including cephalexin, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups.

Animal Data In animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500 mg/kg/day (approximately 0.6 and 1.2 times the MRHD) based on body surface area, respectively during the period of organogenesis showed no adverse effects on embryofetal development. In a pre-and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or 500 mg/kg/day of cephalexin from Day 15 of pregnancy to litter Day 21 showed no adverse effects on parturition, litter size, or growth of offspring.

8.2Lactation Risk Summary Data from a published clinical lactation study reports that cephalexin is present in human milk. The Relative Infant Dose (RID) is considered to be <1% of the maternal weight adjusted dose. There are no data on the effects of cephalexin on the breastfed child or on milk production.

The development of health benefits of breastfeeding should be considered along with the mother’s clinical need for cephalexin and any potential adverse effects on the breastfed child from cephalexin or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of cephalexin in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see Dosage and Administration (2.2 )]

8.5Geriatric 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 [see Warnings and Precautions (5.4 )]

8.6Renal Impairment Cephalexin should be administered with careful monitoring in the presence of renal impairment (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended [see Dosage and Administration (2.3)].Monitor patients longer for toxicity and drug interactions due to delayed clearance.

🆘 Overdosage 44 words ▾

10. 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 3 words ▾

12. Clinical Pharmacology

📦 How Supplied / Storage and Handling 111 words ▾

16. How Supplied/Storage and Handling The 500 mg capsules are a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink. They are available as follows: Bottles of 20 Capsules: NDC 80425-0121-04 Bottles of 28 Capsules: NDC 80425-0121-01 Bottles of 30 Capsules: NDC 80425-0121-03 Bottles of 40 Capsules: NDC 80425-0121-02 Bottles of 14 Capsules: NDC 80425-0121-05 Bottles of 5 Capsules: NDC 80425-0121-06 Bottles of 6 Capsules: NDC 80425-0121-07 Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

📋 Description 155 words ▾

11. Description Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate.

Cephalexin has the molecular formula C 16 H 17 N3O4S•H2O and the molecular weight is 365.41. Cephalexin has the following structural formula: Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD & C Blue No.

1, D & C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD & C Red No.

40; 333 mg and 750 mg Capsules contains FD & C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide.

Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg. Structure

🧪 Nonclinical Toxicology 69 words ▾

13. Non Clinical Toxicology

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon body surface area.

📄 Package Label / Principal Display Panel 17 words ▾

Principal Display Panel label 1 label 2 label 3 labe 4 label 5 albel 6 Cephalexin #6

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

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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx Pharmacy of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 5 capsules (80425-0121-06), 6 capsules (80425-0121-07), 14 capsules (80425-0121-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Advanced Rx Pharmacy of Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 80425-0120-02 · Advanced 80425-0122-02 · Advanced →
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.