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United States · US · US:0527-2370_371e26cf-af95-77d5-e063-6294a90a34b5
azithromycin
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1105272370206 TABLET, FILM COATED in 1 BLISTER PACK (0527-2370-20)
- ndc11052723703230 TABLET, FILM COATED in 1 BOTTLE (0527-2370-32)
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A209045
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azithromycin Tablet
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": "0527-2370_371e26cf-af95-77d5-e063-6294a90a34b5",
"productndc": "0527-2370",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209045",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Dec 7, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZITHROMYCIN DIHYDRATE",
"shortage_reason": "Azithromycin Tablet",
"shortage_status": "current",
"proprietary_name": "azithromycin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209045",
"marketing_category": "ANDA",
"nonproprietary_name": "AZITHROMYCIN",
"start_marketing_date": "20190704",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01FA10.
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