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Two medicines, side by side

Cefdinir vs cephalexin

Cefdinir and cephalexin are both labeled for bacterial infections. Drugs@FDA records approvals of cefdinir since 1997 and of cephalexin since 1971. Pharmacies paid $0.458 per cefdinir 300 mg capsule and $0.120 per cephalexin 500 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.

Check it at the source: the cefdinir FDA label on DailyMed (effective October 14, 2025); the cephalexin FDA label on DailyMed (effective December 31, 2020).

Highlights of the cefdinir record

Cefdinir (Omnicef) · label of October 14, 2025

Used for

From the label: indications

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. […]

On the market

Earliest approval on file
December 4, 1997
Generic labelers
26 labelers
Pharmacy cost
$0.458 per capsule

Supply and safety

Shortage
No current entry
Recalls
11

Highlights of the cephalexin record

Cephalexin (Keflex) · label of December 31, 2020

Used for

From the label: indications

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 […]

On the market

Earliest approval on file
January 4, 1971
Generic labelers
35 labelers
Pharmacy cost
$0.120 per capsule

Supply and safety

Shortage
No current entry
Recalls
22

Source: FDA drug labels via openFDA (Cefdinir label of October 14, 2025, Cephalexin label of December 31, 2020); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do cefdinir and cephalexin differ on the record?

Both are in FDA's class cephalosporin antibacterials.

Generics: cefdinir since 2006; cephalexin since 1976 (Drugs@FDA).

CefdinirCephalexin
Labeled forBacterial infectionsBacterial infections, Urinary tract infections
Pharmacologic classCephalosporin AntibacterialCephalosporin Antibacterial
How it works (label)n/aCephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )].
Half-life (label)n/an/a
Earliest approval on file (Drugs@FDA)December 4, 1997January 4, 1971
First generic approvedMay 19, 2006April 26, 1976
Generic labelers (NDC)26 labelers35 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.458 per capsule (Cefdinir 300 mg capsule)$0.120 per capsule (Cephalexin 500 mg capsule)
12-month price change+0.7%-6%
Boxed warningNoNo
Shortage nowNo current entryNo current entry
Recalls recorded1122
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)7,62821,515
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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