🇺🇸
United States · US · US:70771-1423_654b77ea-07ad-4747-ac35-5a2eb41f4588
Azithromycin
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170771142321 BOTTLE in 1 CARTON (70771-1423-2) / 15 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A211147
ABAB
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": "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": "70771-1423_654b77ea-07ad-4747-ac35-5a2eb41f4588",
"productndc": "70771-1423",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "211147",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE/5ML",
"product_no": "001",
"approval_date": "Jul 31, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE/5ML",
"product_no": "002",
"approval_date": "Jul 31, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZITHROMYCIN DIHYDRATE",
"shortage_reason": "Azithromycin Injection",
"shortage_status": "current",
"proprietary_name": "Azithromycin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA211147",
"marketing_category": "ANDA",
"nonproprietary_name": "Azithromycin",
"start_marketing_date": "20180806",
"active_numerator_strength": "200"
}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.