🇺🇸
United States · US · US:0069-0400_87b9089f-c9cd-41c9-9358-29f6e4014af6
Zithromax
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11006904001010 VIAL in 1 CARTON (0069-0400-10) / 5 mL in 1 VIAL (0069-0400-01)
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
N050733
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azithromycin Injection
Raw payload (JSON)
{
"unii": {
"unii": "5FD1131I7S",
"rxcui": "253155",
"inchikey": "SRMPHJKQVUDLQE-KUJJYQHYSA-N",
"display_name": "AZITHROMYCIN DIHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"db52b91e-79f7-4cc1-9564-f2eee8e31c45": {
"match": "brand_token",
"title": "ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "48",
"published_date": "2026-01-08"
}
},
"productid": "0069-0400_87b9089f-c9cd-41c9-9358-29f6e4014af6",
"productndc": "0069-0400",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "050733",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jan 30, 1997"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZITHROMYCIN DIHYDRATE",
"shortage_reason": "Azithromycin Injection",
"shortage_status": "current",
"proprietary_name": "Zithromax",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA050733",
"marketing_category": "NDA",
"nonproprietary_name": "azithromycin dihydrate",
"start_marketing_date": "20140307",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01FA10.
Access this data programmatically
Query Zithromax 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.