Two medicines, side by side
Azithromycin vs cephalexin
Azithromycin and cephalexin are both labeled for bacterial infections. Drugs@FDA records approvals of azithromycin since 1991 and of cephalexin since 1971. Pharmacies paid $0.266 per azithromycin 250 mg tablet and $0.120 per cephalexin 500 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Azithromycin's other strengths are brand-only: $98.51 per mL (Azasite 1% eye drops). In FDA's classes, azithromycin is a macrolide antimicrobial and cephalexin a cephalosporin antibacterial.
Check it at the source: the azithromycin FDA label on DailyMed (effective December 4, 2025); the cephalexin FDA label on DailyMed (effective December 31, 2020).
Highlights of the azithromycin record
Azithromycin (Zithromax) · label of December 4, 2025
Used for
From the label: indicationsAzithromycin tablets are macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. […]
On the market
- Earliest approval on file
- November 1, 1991
- Generic labelers
- 55 labelers
- Pharmacy cost
- $0.266 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 11
Highlights of the cephalexin record
Cephalexin (Keflex) · label of December 31, 2020
Used for
From the label: indicationsCephalexin 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 (Azithromycin label of December 4, 2025, Cephalexin label of December 31, 2020); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do azithromycin and cephalexin differ on the record?
In FDA's classes, azithromycin is a macrolide antimicrobial and cephalexin a cephalosporin antibacterial.
How each works, in its label's words: Azithromycin, “Azithromycin is a macrolide antibacterial drug. [see Microbiology ( 12.4 )]”; Cephalexin, “Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )].”
Generics: azithromycin since 2005; cephalexin since 1976 (Drugs@FDA).
| Azithromycin | Cephalexin | |
|---|---|---|
| Labeled for | Bacterial infections | Bacterial infections, Urinary tract infections |
| Pharmacologic class | Macrolide Antimicrobial | Cephalosporin Antibacterial |
| How it works (label) | Azithromycin is a macrolide antibacterial drug. [see Microbiology ( 12.4 )] | Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )]. |
| Half-life (label) | Elimination Plasma concentrations of azithromycin following single 500 mg oral and IV doses declined in a polyphasic pattern resulting in a mean apparent plasma clearance of 630 mL/min and terminal elimination half-life … | n/a |
| Earliest approval on file (Drugs@FDA) | November 1, 1991 | January 4, 1971 |
| First generic approved | November 14, 2005 | April 26, 1976 |
| Generic labelers (NDC) | 55 labelers | 35 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.266 per tablet (Azithromycin 250 mg tablet) | $0.120 per capsule (Cephalexin 500 mg capsule) |
| 12-month price change | -26% | -6% |
| Boxed warning | No | No |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 11 | 22 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 59,712 | 21,515 |
| DEA schedule | none | none |
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?
- Alternatives to azithromycin
- every medicine labeled for the same conditions