Medicine
Clarithromycin 500 mg tablet
Clarithromycin 500 mg tablet is a generic prescription medicine for oral use, made by 23 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 at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Clarithromycin
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 60 tablets, 1000 tablets and 104 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaProficient RxPD-Rx PharmaceuticalsA-S Medication SolutionsChartwell RXLannettRising Pharma HoldingsSandozSolaris Pharma23 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- 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
- 25 August 2005
- Identifiers
- RxCUI 197517, 197516DailyMed set ID 25debd85-0840-4f8d-9898-027772061dd2, 1920f943-bbf1-cfd9-7475-96a35680a9e0, 2d6cfd87-9b8c-bba9-e063-6294a90aff5a +31NDC 50090-1830, 50268-179, 67046-1515 +31Application ANDA065489, ANDA065136, ANDA203584 +2
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
A sample of 40 packs from 23 labelers. The register lists 107 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 46708-345-30 | Alembic PharmaceuticalsIndia | 1 February 2022 |
| 60 tablet, film coated in 1 bottle | 46708-345-60 | Alembic PharmaceuticalsIndia | 1 February 2022 |
| 1000 tablet, film coated in 1 bottle | 46708-345-91 | Alembic PharmaceuticalsIndia | 1 February 2022 |
| 30 tablet, film coated in 1 bottle | 62332-345-30 | Alembic PharmaceuticalsIndia | 1 February 2022 |
| 60 tablet, film coated in 1 bottle | 62332-345-60 | Alembic PharmaceuticalsIndia | 1 February 2022 |
| 1000 tablet, film coated in 1 bottle | 62332-345-91 | Alembic PharmaceuticalsIndia | 1 February 2022 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-226-10 | Aurobindo PharmaIndia | 25 July 2012 |
| 60 tablet, film coated in 1 bottle | 65862-226-60 | Aurobindo PharmaIndia | 25 July 2012 |
| 1000 tablet, film coated in 1 bottle | 65862-226-99 | Aurobindo PharmaIndia | 25 July 2012 |
| 60 tablet, film coated in 1 bottle, plastic | 62135-615-60 | Chartwell RX | 1 February 2021 |
| 60 tablet, film coated in 1 bottle, plastic | 0527-1932-06 | Lannett | 23 November 2019 |
| 60 tablet, film coated in 1 bottle | 57237-045-60 | Rising Pharma Holdings | 25 July 2012 |
| 60 tablet in 1 bottle | 0781-1962-60 | Sandoz | 25 August 2005 |
| 60 tablet, film coated in 1 bottle, plastic | 73473-910-60 | Solaris Pharma | 23 November 2019 |
| 14 tablet, film coated in 1 bottle, plastic | 63187-376-14 | Proficient Rx | 7 November 2025 |
| 20 tablet, film coated in 1 bottle, plastic | 63187-376-20 | Proficient Rx | 29 December 2021 |
| 28 tablet, film coated in 1 bottle, plastic | 63187-376-28 | Proficient Rx | 1 September 2016 |
| 30 tablet, film coated in 1 bottle, plastic | 63187-376-30 | Proficient Rx | 1 September 2016 |
| 60 tablet, film coated in 1 bottle, plastic | 63187-376-60 | Proficient Rx | 1 September 2016 |
| 90 tablet, film coated in 1 bottle, plastic | 63187-376-90 | Proficient Rx | 29 December 2021 |
| 14 tablet, film coated in 1 bottle | 63187-625-14 | Proficient Rx | 1 December 2018 |
| 28 tablet, film coated in 1 bottle | 63187-625-28 | Proficient Rx | 1 December 2018 |
| 60 tablet, film coated in 1 bottle | 63187-625-30 | Proficient Rx | 1 December 2018 |
| 30 tablet, film coated in 1 bottle | 63187-625-60 | Proficient Rx | 1 December 2018 |
| 90 tablet, film coated in 1 bottle | 63187-625-90 | Proficient Rx | 1 December 2018 |
| 20 tablet in 1 bottle | 82804-069-20 | Proficient Rx | 1 February 2024 |
| 30 tablet in 1 bottle | 82804-069-30 | Proficient Rx | 1 February 2024 |
| 60 tablet in 1 bottle | 82804-069-60 | Proficient Rx | 1 February 2024 |
| 90 tablet in 1 bottle | 82804-069-90 | Proficient Rx | 1 February 2024 |
| 14 tablet, film coated in 1 bottle | 82804-141-14 | Proficient Rx | 2 April 2026 |
| 20 tablet, film coated in 1 bottle | 82804-141-20 | Proficient Rx | 19 February 2026 |
| 28 tablet, film coated in 1 bottle | 82804-141-28 | Proficient Rx | 17 September 2024 |
| 14 tablet in 1 bottle, plastic | 43063-530-14 | PD-Rx Pharmaceuticals | 30 September 2013 |
| 20 tablet in 1 bottle, plastic | 43063-530-20 | PD-Rx Pharmaceuticals | 30 September 2013 |
| 14 tablet, film coated in 1 bottle, plastic | 43063-752-14 | PD-Rx Pharmaceuticals | 23 November 2019 |
| 20 tablet, film coated in 1 bottle, plastic | 43063-752-20 | PD-Rx Pharmaceuticals | 23 November 2019 |
| 28 tablet, film coated in 1 bottle, plastic | 43063-752-28 | PD-Rx Pharmaceuticals | 23 November 2019 |
| 20 tablet, film coated in 1 bottle, plastic | 43063-823-20 | PD-Rx Pharmaceuticals | 8 January 2018 |
| 28 tablet, film coated in 1 bottle, plastic | 43063-823-28 | PD-Rx Pharmaceuticals | 22 February 2018 |
| 20 tablet, film coated in 1 bottle | 50090-1830-0 | A-S Medication Solutions | 18 May 2015 |
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 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.