🇺🇸
United States · US · US:55695-002_1287e725-48d5-e23e-e063-6394a90a96ac
Azithromycin
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSTATE HEALTH SERVICES, TEXAS DEPARTMENT OF
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11556950020015 mL in 1 BOTTLE (55695-002-00)
Annotations
UNII (FDA Substance ID)
JTE4MNN1MD
AZITHROMYCIN MONOHYDRATE
RxCUI 1298839
Orange Book
A065246
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azithromycin Injection
Raw payload (JSON)
{
"unii": {
"unii": "JTE4MNN1MD",
"rxcui": "1298839",
"inchikey": "HQUPLSLYZHKKQT-WVVFQGGUSA-N",
"display_name": "AZITHROMYCIN MONOHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b5d79719-b1dc-469f-a19c-f8ba615138f0": {
"match": "brand_token",
"title": "AZITHROMYCIN TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-05-20"
}
},
"productid": "55695-002_1287e725-48d5-e23e-e063-6394a90a96ac",
"productndc": "55695-002",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "065246",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE/5ML",
"product_no": "001",
"approval_date": "Jul 5, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE/5ML",
"product_no": "002",
"approval_date": "Jul 5, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZITHROMYCIN MONOHYDRATE",
"shortage_reason": "Azithromycin Injection",
"shortage_status": "current",
"proprietary_name": "Azithromycin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA065246",
"marketing_category": "ANDA",
"nonproprietary_name": "Azithromycin",
"start_marketing_date": "20101228",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J01FA10.
Access this data programmatically
Query Azithromycin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.