Medicine
Azithromycin 100 mg/5 mL powder for oral suspension
Azithromycin 100 mg/5 mL powder for oral suspension is a generic prescription medicine for oral use, made by 11 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
Protect from freezing. Store dry powder at 20° to 25°C (68° to 77°F)…
Key facts
- Active ingredient (INN)
- Azithromycin
- Brand
- Sold under the generic name
- Strength
- 100 mg/5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 1 bottle, 15 mL and 10 more
- Manufacturers
- Zydus LifesciencesIndiaAurobindo PharmaIndiaNuCare Pharmaceuticals,IncA-S Medication SolutionsAiPing PharmaceuticalEpic PharmaPreferred PharmaceuticalsSlate Run PharmaceuticalsState Health Services, Texas Department ofTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store dry powder at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.
- 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
- 28 December 2010
- Identifiers
- RxCUI 141963, 308459DailyMed set ID d6fb42ed-7dac-4a7b-9964-d367dd47dd5c, 0b63649d-558c-4250-90ee-af6e1e5c6d2c, 3c902990-b870-4725-b9fe-76b8be633e1c +10NDC 11788-128, 70771-1422, 59651-007 +10Application ANDA217036, ANDA211147, ANDA209201 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 15 mL in 1 bottle | 70710-1457-1 | Zydus LifesciencesIndia | 6 August 2018 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 70771-1422-1 | Zydus LifesciencesIndia | 6 August 2018 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 59651-007-15 | Aurobindo PharmaIndia | 9 October 2018 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 11788-128-13 | AiPing Pharmaceutical | 16 January 2026 |
| 15 mL in 1 bottle, plastic | 42806-147-31 | Epic Pharma | 10 April 2018 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 70436-220-34 | Slate Run Pharmaceuticals | 1 January 2024 |
| 15 mL in 1 bottle | 55695-002-00 | State Health Services, Texas Department of | 28 December 2010 |
| 15 mL in 1 bottle | 0093-2027-23 | Teva Pharmaceuticals | 28 December 2010 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 72673-084-30 | Zhejiang Poly Pharm | 11 April 2025 |
| 15 mL in 1 bottle | 68071-1527-5 | NuCare Pharmaceuticals,Inc | 18 July 2017 |
| 15 mL in 1 bottle | 68071-5035-5 | NuCare Pharmaceuticals,Inc | 21 August 2019 |
| 15 mL in 1 bottle | 50090-1868-0 | A-S Medication Solutions | 10 June 2015 |
| 15 mL in 1 bottle | 68788-8675-1 | Preferred Pharmaceuticals | 23 May 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 100 mg/5 mL powder for oral suspension 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.