Quick answers
- What is Clarithromycin used for?
- The FDA-approved label (Clarithromycin, Remedyrepack Inc., June 24, 2026) says: “Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults Acute Maxillary Sinusitis Community-Acquired Pneumonia Pharyngitis/Tonsillitis Uncomplicated Skin and Skin Structure Infections Acute Otitis Media in Pediatric Patients Treatment and Prophylaxis of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clarithromycin have a boxed warning?
- No. None of the 39 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Clarithromycin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clarithromycin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Clarithromycin?
- 25 companies list prescription products of Clarithromycin in the FDA NDC Directory, including Sandoz Inc, Sportpharm LLC and PD-Rx Pharmaceuticals, Inc..
What Clarithromycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults Acute Maxillary Sinusitis Community-Acquired Pneumonia Pharyngitis/Tonsillitis Uncomplicated Skin and Skin Structure Infections Acute Otitis Media in Pediatric Patients Treatment and Prophylaxis of …
— FDA label: Clarithromycin, Remedyrepack Inc., effective June 24, 2026. Read the full label on DailyMed →
The FDA has 39 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 39 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, film coated, extended release · For suspension |
|---|---|
| Route | Oral |
| Prescription products | 54 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| clarithromycin 125 mg/5 mL for suspension | Generic | $0.9258 per mL |
| clarithromycin 250 mg tablet, film coated | Generic | $0.3887 per tablet |
| clarithromycin 250 mg/5 mL for suspension | Generic | $1.32–$1.56 per mL 2 packages, lowest to highest |
| clarithromycin 500 mg tablet, film coated | Generic | $0.4668 per tablet |
| clarithromycin 500 mg tablet, film coated, extended release | Generic | $1.89 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sandoz Inc4 products
- Sportpharm LLC4 products
- PD-Rx Pharmaceuticals, Inc.4 products
- A-S Medication Solutions4 products
- Proficient Rx LP4 products
- Lannett Company, Inc.3 products
- Solaris Pharma Corporation3 products
- Chartwell RX, LLC3 products
- AvPAK2 products
- Alembic Pharmaceuticals Inc.2 products
- American Health Packaging2 products
- Rising Pharma Holdings, Inc.2 products
- Aurobindo Pharma Limited2 products
- Alembic Pharmaceuticals Limited2 products
- Northwind Health Company, LLC2 products
- Bryant Ranch Prepack2 products
- Actavis Pharma, Inc.1 product
- Preferred Pharmaceuticals Inc.1 product
- Direct_Rx1 product
- NuCare Pharmaceuticals, Inc.1 product
- Remedyrepack Inc.1 product
- Asclemed USA, Inc.1 product
- Major Pharmaceuticals1 product
- DirectRx1 product
- Coupler LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (9)
- ANDA065145Actavis Labs Fl Inc · June 24, 2004
- ANDA065136Sandoz · August 25, 2005
- ANDA065144Sandoz · October 18, 2005
- ANDA065384Chartwell · August 20, 2007
- ANDA065283Sandoz · September 4, 2007
- ANDA065489Aurobindo · July 25, 2012
- ANDA203584Hec Pharm · September 28, 2015
- ANDA208987Sunshine · July 9, 2018
- ANDA210459Alembic · January 31, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 197516, 197517, 309322, 359385 |
|---|---|
| SPL set ID of the quoted label | 9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6 |
| FDA labels (SPL) | 39 |
| FDA applications | 9 ANDA |
| Active ingredients (FDA) | CLARITHROMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Clarithromycin, Remedyrepack Inc., effective June 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →