United States· US:82584-307_1e292167-581f-b1db-e063-6394a90ae8a1
AZASITE
A azithromycin product containing azithromycin monohydrate, registered in United States by Thea Pharma Inc.. The same ATC class is registered in 11 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Azithromycin is registered in 11 of 19 countries.
Countries holding a registration under ATC S01AA26 (azithromycin), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 7 of them publish a price we can compare per daily dose
Azithromycin · ATC S01AA26
11 / 19 countries
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- AZITHROMYCIN MONOHYDRATE
- Manufacturer
- Thea Pharma Inc.
- Country
- United States (US)
- ATC code
- S01AA26
- ATC class
- Azithromycin
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1182584307021 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPER
- ndc1182584307031 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER
- ndc1182584-307-02
- ndc1182584-307-03
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Azithromycin in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- Italy · Azitromicina Sandoz Gmbh
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/7badc6b5-291f-4eee-bd9f-c2c3fa4dac93 GET /v1/drugs/7badc6b5-291f-4eee-bd9f-c2c3fa4dac93?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "OPHTHALMIC",
"source": "ndc",
"strength": "10",
"substance": "AZITHROMYCIN MONOHYDRATE",
"productndc": "82584-307",
"dosage_form": "SOLUTION/ DROPS",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA050810",
"marketing_category": "NDA"
}See everything about azithromycin.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.