Medicine
Zithromax 200 mg/5 mL powder for oral suspension
Zithromax 200 mg/5 mL powder for oral suspension is a prescription medicine containing Azithromycin for oral use, marketed by Pfizer Laboratories, 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 ZITHROMAX tablets between 15° to 30°C (59° to 86°F). Storage and…
Key facts
- Active ingredient (INN)
- Azithromycin
- Brand
- Zithromax
- Strength
- 200 mg/5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Pfizer Laboratories
- Manufacturer
- Pfizer Laboratories
- Origin register
- US FDA, United States
- Storage
- Store ZITHROMAX tablets between 15° to 30°C (59° to 86°F). Storage and Handling Store dry powder below 30°C (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
- 19 October 1995
- Identifiers
- RxCUI 105260, 141963, 211307 +7DailyMed set ID db52b91e-79f7-4cc1-9564-f2eee8e31c45NDC 0069-3140, 0069-3130, 0069-3120Application NDA050710
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 15 mL in 1 bottle | 0069-3120-19 | Pfizer Laboratories | 19 October 1995 |
| 1 bottle in 1 carton / 22.5 mL in 1 bottle | 0069-3130-19 | Pfizer Laboratories | 19 October 1995 |
| 1 bottle in 1 carton / 30 mL in 1 bottle | 0069-3140-19 | Pfizer Laboratories | 19 October 1995 |
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 200 mg/5 mL powder for oral suspension.
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 Zithromax 200 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.