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Cephalexin 500 mg Capsule, 4-count

by A-S Medication Solutions · 4 CAPSULE in 1 BOTTLE, PLASTIC (50090-3199-8)

NDC 50090-3199-08

🏷️ FDA NDC (as labeled) 50090-3199-8 billing pads the package segment with a zero

This package

Contains4-count Pack sizes8 compare ↓

Also priced by: Part D plans $0.1952/unit — full pricing hub ↓

Also comes in: 10 capsules 50090-3199-05 14 capsules 50090-3199-03 20 capsules 50090-3199-00 28 capsules 50090-3199-01 30 capsules 50090-3199-06 40 capsules 50090-3199-02 100 capsules 50090-3199-07

Rx only Generic On market Non-controlled

🗂️ Data synced 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 Dr. Brian Staiger, PharmD

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 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

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 50090-3199-8

Product NDC 50090-3199

11-digit billing NDC 50090319908

NCPDP billing unit EA — each (per item)

RxCUI 309112, 309114

UNII OBN7UDS42Y

Application # ANDA090836

SPL Set ID 7cbdfa7f-2ea0-48e1-b506-59f58e5685a6

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

GPI-14 02100020000110

GPI class Cephalexin

GCN Seq No 009043

GCN 39802

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 CAPSULE

FDB brand name Cephalexin

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 50090-3199-8 — 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 → 50090-3199-08. 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.

🏭 Manufacturer & labeler

LabelerA-S Medication Solutions

Application holderALKEM LABORATORIES LTD

FDA applicationANDA090836 (ANDA)

Labeler code50090

First marketedJan 2011

Product typeHuman Prescription Drug

Portfolio2,774 products on file

🔎 All NDCs from A-S Medication Solutions

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.

🩺 Clinical

Label name CEPHALEXIN 500 MG CAPSULE Ingredient Cephalexin

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Cephalexin — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Cephalexin (61 interactions) — ranked by severity →

Nutrient depletion considerations

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

BIOTIN Insignificant Depletion FOLIC ACID Insignificant Depletion RIBOFLAVIN Insignificant Depletion THIAMINE Insignificant Depletion VITAMIN B12 Insignificant Depletion +2 more

🧪 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.

💊 What it looks like

Color Green

ShapeCapsule

Imprint220

Size18 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.

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

UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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 WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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.

13 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.

💲 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 system	Per each	Per 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	$0.78 / 4 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Cephalexin 500 mg 00093-3147-01	Teva	100 capsules	$0.121	AB	Discontinued	—
Cephalexin 500 mg 00904-7337-06	Major	50 capsules	$0.121	AB	Availability likely	—
Cephalexin 500 mg 50268-0152-15	AvPAK	50 capsules	$0.121	AB	Availability likely	—
Cephalexin 500 mg 60687-0163-01	American	100 capsules	$0.121	AB	Availability likely	—
Cephalexin 500 mg 62135-0711-74	Chartwell	40 capsules	$0.121	AB	Availability likely	—
Cephalexin 500 mg 65862-0019-01	Aurobindo	100 capsules	$0.121	AB	Availability likely	—
Cephalexin 500 mg 67877-0219-01	Ascend	100 capsules	$0.121	AB	Availability likely	—
Cephalexin 500 mg 68180-0122-01	Lupin	100 capsules	$0.121	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 mgthis 50090-3199-08	A-S	4 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 mg 80425-0121-01	Advanced	28 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Cephalexin — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease2,157

Renal Failure1,558

Acute Kidney Injury1,550

Diarrhoea1,405

Pain1,397

Fatigue1,303

Nausea1,297

Reporter sex

Serious outcomes

Hospitalization7,494

Death1,794

Disabling724

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
50090-3199-00	20 CAPSULE in 1 BOTTLE (50090-3199-0)	2017-10-23	Active
50090-3199-01	28 CAPSULE in 1 BOTTLE (50090-3199-1)	2017-12-01	Active
50090-3199-02	40 CAPSULE in 1 BOTTLE (50090-3199-2)	2017-12-18	Active
50090-3199-05	10 CAPSULE in 1 BOTTLE (50090-3199-5)	2018-03-05	Active
50090-3199-06	30 CAPSULE in 1 BOTTLE (50090-3199-6)	2017-10-23	Active
50090-3199-07	100 CAPSULE in 1 BOTTLE (50090-3199-7)	2018-11-06	Active
50090-3199-08 You're viewing this	4 CAPSULE in 1 BOTTLE, PLASTIC (50090-3199-8)	2014-11-28	Active
50090-3199-03	14 CAPSULE in 1 BOTTLE (50090-3199-3)	2017-12-04	Active

You're viewing the smallest of 8 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 50090-3199-08?

NDC 50090-3199-08 is a 4-count package — 4 capsule in 1 bottle, plastic.

What is the difference between NDC 50090-3199-08 and NDC 50090-3199-05?

Both are Cephalexin 500 mg Capsule — the drug itself is identical. NDC 50090-3199-08 is the 4-count package, while NDC 50090-3199-05 is the 10 capsules package.

What NDC number is used to bill for this package of Cephalexin 500 mg Capsule?

Bill NDC 50090-3199-08 — the 11-digit billing format is 50090319908. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	✓ 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 FDA registers it as 50090-3199-8, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50090-3199-08, written without dashes as 50090319908. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 50090-3199-08, the first segment (50090) is the labeler code FDA assigned to A-S Medication Solutions; the middle segment (3199) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.

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 A-S Medication Solutions. 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 7 other package presentations of this same product, including 10 capsules (50090-3199-05), 14 capsules (50090-3199-03), 20 capsules (50090-3199-00). 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?

A-S Medication Solutions 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.

📄 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS & USAGE Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections (1.4) Genitourinary tract infections ( 1.5 ) 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 bacteria.

(1.6)

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 ~2 min read ▾

2 DOSAGE & ADMINISTRATION Adults and 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 ( 2.1 ) Pediatric patients (over 1 year of age) Otitis media: 75 to 100 mg/kg in equally divided doses every 6 hours ( 2.2 ) All other indications: 25 to 50 mg/kg given in equally divided doses ( 2.2 ) In severe infections: 50 to 100 mg/kg may be administered in equally divided doses ( 2.2 ) Duration of therapy ranges from 7 to14 days depending on the infection type and severity.

( 2 ) Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min. ( 2.3 )

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 165 words ▾

3 DOSAGE FORMS & 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. Capsules: 250 mg, 333 mg, 500 mg and 750 mg ( 3 )

⛔ Contraindications 39 words ▾

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

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions : Prior to use, inquire regarding history of hypersensitivity to beta-lactam antibacterial drugs. Discontinue the drug if signs or symptoms of an allergic reaction occur and institute supportive measures. ( 5.1 ) Clostridium difficile-associated diarrhea (CDAD ): Evaluate if diarrhea occurs.

( 5.2 ) Direct Coomb’s Test Seroconversion : If anemia develops during or after cephalexin therapy, evaluate for drug-induced hemolytic anemia. ( 5.3 ) Seizure Potential : Use lower dose in patients with renal impairment. ( 5.4 )

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 ~2 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 ) ] The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 140 words ▾

7 DRUG INTERACTIONS Metformin: increased metformin concentrations. Monitor for hypoglycemia. ( 7.1 ) Probenecid- The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended. ( 7.2 ) Administration of cephalexin may result in a false-positive reaction glucose in the urine. ( 7.3 )

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 Renal Impairment: Monitor patients longer for toxicity and drug interactions due to delayed clearance. ( 8.6 )

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 (…

🤰 Pregnancy ~1 min read ▾

🧒 Pediatric Use 34 words ▾

🧓 Geriatric Use 104 words ▾

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [ see Warnings and Precautions ( 5.4 )]

🆘 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 ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )]

12.3Pharmacokinetics Absorption: Cephalexin is acid stable and may be given without regard to meals. 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).

Distribution: Cephalexin is approximately 10% to 15% bound to plasma proteins. Excretion: 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 1000, 2200, and 5000 mcg/mL respectively. Drug Interactions: 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.

12.4Microbiology Mechanism of Action Cephalexin is a bactericidal agent that acts by the inhibition of bacterial 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 vulgaris.

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 has been shown to be active against most isolates of the following bacteria both in vitro and in clinical infections [ see Indications and Usage (1) ] Gram-positive bacteria Staphylococcus aureus (methicillin-susceptible isolates only) Streptococcus pneumoniae (penicillin-susceptible isolates) 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.

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )]

📦 How Supplied / Storage and Handling 136 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-3199 NDC: 50090-3199-0 20 CAPSULE in a BOTTLE NDC: 50090-3199-1 28 CAPSULE in a BOTTLE NDC: 50090-3199-2 40 CAPSULE in a BOTTLE NDC: 50090-3199-3 14 CAPSULE in a BOTTLE NDC: 50090-3199-5 10 CAPSULE in a BOTTLE NDC: 50090-3199-6 30 CAPSULE in a BOTTLE NDC: 50090-3199-8 4 CAPSULE in a BOTTLE, PLASTIC NDC: 50090-3199-7 100 CAPSULE in a BOTTLE Product: 50090-3202 NDC: 50090-3202-2 20 CAPSULE in a BOTTLE NDC: 50090-3202-3 28 CAPSULE in a BOTTLE NDC: 50090-3202-4 40 CAPSULE in a BOTTLE NDC: 50090-3202-5 30 CAPSULE in a BOTTLE NDC: 50090-3202-8 4 CAPSULE in a BOTTLE NDC: 50090-3202-0 5 CAPSULE in a BOTTLE NDC: 50090-3202-1 14 CAPSULE in a BOTTLE NDC: 50090-3202-6 8 CAPSULE in a BOTTLE NDC: 50090-3202-7 16 CAPSULE in a BOTTLE NDC: 50090-3202-9 12 CAPSULE in a BOTTLE

📋 Description 161 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 N 3 O 4 S•H 2 O 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. cephalexin-str

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Allergic Reactions 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, other beta-lactams (including cephalosporins) or other allergens ( 5.1 ) Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection.

If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider Antibacterial Resistance Counsel patients that antibacterial drugs including cephalexin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin is prescribed to treat a bacterial infection, tell patients 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 or other antibacterial drugs in the future. Manufactured by : Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: November, 2021 PT 1199-11

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

arthralgia: Joint pain.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bactericidal: Describes a medicine that kills bacteria outright.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

gastritis: Swelling or irritation of the lining of the stomach.

hematuria: Blood in the urine.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemolysis: The breaking apart of red blood cells, which can lower the number of cells available to carry oxygen.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancytopenia: A low level of all three main blood cell types at once: red cells, white cells, and platelets.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

prothrombin time: A blood test that measures how many seconds it takes for blood to form a clot.

pruritus: Itching of the skin.

refractory: Describing a disease that does not respond to, or improve with, treatment.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

superinfection: A new, second infection that appears during treatment of the first one, often caused by germs the medicine does not kill.

susceptibility testing: A lab test that grows germs from a sample and checks which medicines can stop or kill them.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 50090-3185-00 · A-S 50090-3200-00 · A-S →

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.

Cephalexin 500 mg Capsule, 4-count

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