Medicine
Azithromycin 500 mg tablet
Azithromycin 500 mg tablet is a generic prescription medicine for oral use, made by 27 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
NDC: 72162-2669-2: 3 Tablets in a BOTTLE NDC: 72162-2669-3: 30 Tablets in a…
Key facts
- Active ingredient (INN)
- Azithromycin
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 3 blister pack, 30 tablets, 1 blister pack and 119 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaLupinIndiaA-S Medication SolutionsBionpharmaHealth Department, Oklahoma StatePharmPakTeva PharmaceuticalsLannettRising Pharma Holdings27 labelers on the register
- Origin register
- US FDA, United States
- Storage
- NDC: 72162-2669-2: 3 Tablets in a BOTTLE NDC: 72162-2669-3: 30 Tablets in a BOTTLE Azithromycin tablets should be stored at 20° to 25°C (68° to 77°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 248656, 308460, 749780 +1DailyMed set ID 2a8010dc-700f-45d3-94ca-ebe4a51acc1b, a5b4092d-ab72-f5d1-e053-2995a90ac582, 814abe38-da4a-48af-bf4b-2ce04a5aabd1 +37NDC 72162-2669, 72189-088, 0904-7351 +37Application ANDA207398, ANDA210001, ANDA065399 +6
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 27 labelers. The register lists 122 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 3 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 46708-058-03 | Alembic PharmaceuticalsIndia | 29 January 2020 |
| 30 tablet, film coated in 1 bottle | 46708-058-30 | Alembic PharmaceuticalsIndia | 29 January 2020 |
| 3 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 62332-252-03 | Alembic PharmaceuticalsIndia | 29 January 2020 |
| 3 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 62332-252-09 | Alembic PharmaceuticalsIndia | 29 January 2020 |
| 30 tablet, film coated in 1 bottle | 62332-252-30 | Alembic PharmaceuticalsIndia | 29 January 2020 |
| 30 tablet, film coated in 1 bottle | 65862-642-30 | Aurobindo PharmaIndia | 5 July 2018 |
| 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 65862-642-64 | Aurobindo PharmaIndia | 5 July 2018 |
| 3 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 65862-642-90 | Aurobindo PharmaIndia | 5 July 2018 |
| 30 tablet, film coated in 1 container | 68180-862-06 | LupinIndia | 17 November 2022 |
| 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 68180-862-11 | LupinIndia | 17 November 2022 |
| 30 tablet, film coated in 1 bottle | 69452-172-13 | Bionpharma | 12 March 2019 |
| 3 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 69452-172-72 | Bionpharma | 10 October 2019 |
| 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 69452-172-74 | Bionpharma | 10 October 2019 |
| 2 tablet, film coated in 1 packet | 83112-501-00 | Health Department, Oklahoma State | 15 February 2024 |
| 2 tablet, film coated in 1 packet | 83112-501-02 | Health Department, Oklahoma State | 15 February 2024 |
| 4 tablet, film coated in 1 packet | 83112-501-04 | Health Department, Oklahoma State | 15 February 2024 |
| 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 0527-2395-19 | Lannett | 4 July 2019 |
| 30 tablet, film coated in 1 bottle | 0527-2395-32 | Lannett | 4 July 2019 |
| 1 bottle in 1 box / 1 tablet, film coated in 1 bottle | 54348-857-00 | PharmPak | 10 July 2019 |
| 1 bottle in 1 box / 1 tablet, film coated in 1 bottle | 54348-857-01 | PharmPak | 10 July 2019 |
| 1 bottle in 1 box / 2 tablet, film coated in 1 bottle | 54348-857-02 | PharmPak | 10 July 2019 |
| 30 tablet, film coated in 1 bottle | 64980-726-03 | Rising Pharma Holdings | 3 June 2026 |
| 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 64980-726-13 | Rising Pharma Holdings | 3 June 2026 |
| 1 dose pack in 1 carton / 3 tablet, film coated in 1 dose pack | 0781-8090-03 | Sandoz | 14 February 2019 |
| 30 tablet, film coated in 1 bottle | 0781-8090-31 | Sandoz | 14 February 2019 |
| 30 tablet, film coated in 1 bottle | 50111-788-10 | Teva Pharmaceuticals | 6 January 2006 |
| 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 50111-788-55 | Teva Pharmaceuticals | 18 February 2014 |
| 3 carton in 1 package / 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 50111-788-67 | Teva Pharmaceuticals | 6 January 2006 |
| 3 carton in 1 box / 1 tablet, film coated in 1 carton | 50090-4700-0 | A-S Medication Solutions | 8 November 2019 |
| 5 tablet, film coated in 1 bottle | 50090-5366-0 | A-S Medication Solutions | 17 November 2020 |
| 1 tablet, film coated in 1 bottle | 50090-5366-1 | A-S Medication Solutions | 17 November 2020 |
| 2 tablet, film coated in 1 bottle | 50090-5376-0 | A-S Medication Solutions | 19 November 2020 |
| 5 tablet, film coated in 1 bottle | 50090-7298-0 | A-S Medication Solutions | 14 October 2024 |
| 1 tablet, film coated in 1 bottle | 50090-7298-1 | A-S Medication Solutions | 14 October 2024 |
| 2 tablet, film coated in 1 bottle | 50090-7299-0 | A-S Medication Solutions | 14 October 2024 |
| 3 carton in 1 box / 1 tablet, film coated in 1 carton | 50090-7506-0 | A-S Medication Solutions | 17 February 2025 |
| 3 tablet, film coated in 1 bottle | 50090-8013-0 | A-S Medication Solutions | 13 July 2026 |
| 30 tablet, film coated in 1 bottle | 50090-8013-1 | A-S Medication Solutions | 13 July 2026 |
| 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 50090-8017-0 | A-S Medication Solutions | 20 July 2026 |
| 1 blister pack in 1 box / 3 tablet, film coated in 1 blister pack | 63187-189-03 | Proficient Rx | 1 October 2014 |
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
Alternatives
Other makers and brands of Azithromycin 500 mg tablet.
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 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.