Medicine
Azithromycin 600 mg tablet
Azithromycin 600 mg tablet is a generic prescription medicine for oral use, made by 9 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 from 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Azithromycin
- Brand
- Sold under the generic name
- Strength
- 600 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 blister pack, 30 tablets and 9 more
- Manufacturers
- Alembic PharmaceuticalsIndiaLupinIndiaAvKAREBionpharmaCouplerPrecision DoseRemedyrepackSandozTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted from 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
- J01FA10 Azithromycin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 November 2005
- Identifiers
- RxCUI 204844DailyMed set ID b88f5839-8e8b-4bf6-a577-5c8b7cffeec6, 34b70c23-92a6-460f-8dbb-15a0e6b9d3a9, ac549022-4d7f-4c9f-9244-1a2df9a27276 +7NDC 68094-690, 0781-8091, 50111-789 +7Application ANDA207566, ANDA065209, ANDA065218 +3
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 |
|---|---|---|---|
| 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 46708-253-10 | Alembic PharmaceuticalsIndia | 28 January 2020 |
| 30 tablet, film coated in 1 bottle | 46708-253-30 | Alembic PharmaceuticalsIndia | 28 January 2020 |
| 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 62332-253-10 | Alembic PharmaceuticalsIndia | 28 January 2020 |
| 30 tablet, film coated in 1 bottle | 62332-253-30 | Alembic PharmaceuticalsIndia | 28 January 2020 |
| 30 tablet, film coated in 1 container | 68180-863-06 | LupinIndia | 17 November 2022 |
| 30 tablet, film coated in 1 bottle | 69452-173-13 | Bionpharma | 26 December 2018 |
| 30 tablet, film coated in 1 bottle | 0781-8091-31 | Sandoz | 14 February 2019 |
| 30 tablet, film coated in 1 bottle | 50111-789-10 | Teva Pharmaceuticals | 1 December 2005 |
| 30 tablet, film coated in 1 bottle | 42291-044-30 | AvKARE | 24 April 2024 |
| 30 tablet in 1 blister pack | 67046-1503-3 | Coupler | 28 January 2025 |
| 30 tablet, film coated in 1 bottle | 68094-690-30 | Precision Dose | 15 February 2024 |
| 30 tablet, film coated in 1 blister pack | 70518-4202-0 | Remedyrepack | 2 October 2024 |
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 1 November 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 Azithromycin
Clinical summary
Azithromycin is a macrolide antimicrobial indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below, among other approved uses. MedsAcross supplies Azithromycin 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 AzithromycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zithromax prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
Need Azithromycin 600 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.