Medicine
Clarithromycin 500 mg extended-release tablet
Clarithromycin 500 mg extended-release tablet is a generic prescription medicine for oral use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store clarithromycin extended-release tablets, USP at 20º to 25ºC (68º to 77ºF).
Key facts
- Active ingredient (INN)
- Clarithromycin
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets, 14 tablets and 2 more
- Manufacturers
- Actavis PharmaChartwell RXLannettPD-Rx PharmaceuticalsSolaris Pharma
- Origin register
- US FDA, United States
- Storage
- Store clarithromycin extended-release tablets, USP at 20º to 25ºC (68º to 77ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01FA09 Clarithromycin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 February 2014
- Identifiers
- RxCUI 359385DailyMed set ID 4d4303f8-88dd-8b88-e063-6394a90ab48f, 1d328f5d-73c1-4df7-a3df-71d0e0221181, dea5bd78-7f93-4bc4-a2e4-1b021f5fe098 +2NDC 73473-911, 43063-942, 62135-883 +2Application ANDA208987, ANDA065145
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet, film coated, extended release in 1 bottle, plastic | 0591-2805-60 | Actavis Pharma | 27 February 2014 |
| 60 tablet, film coated, extended release in 1 bottle | 62135-883-60 | Chartwell RX | 16 April 2024 |
| 60 tablet, film coated, extended release in 1 bottle | 0527-1930-06 | Lannett | 10 September 2019 |
| 60 tablet, film coated, extended release in 1 bottle | 73473-911-60 | Solaris Pharma | 10 September 2019 |
| 14 tablet, film coated, extended release in 1 bottle, plastic | 43063-942-14 | PD-Rx Pharmaceuticals | 10 September 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 31 October 1991 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Clarithromycin
Clinical summary
Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following, among other approved uses. It is available as tablets, extended-release tablets and powder for oral suspension. MedsAcross supplies Clarithromycin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about ClarithromycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Clarithromycin prescribing information (Solaris Pharma) · U.S. National Library of Medicine, DailyMed
Need Clarithromycin 500 mg extended-release tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.