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United States · US · US:50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387
Azithromycin
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11501117871030 TABLET, FILM COATED in 1 BOTTLE (50111-787-10)
- ndc1150111787511 BLISTER PACK in 1 CARTON (50111-787-51) / 6 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1150111787663 CARTON in 1 PACKAGE (50111-787-66) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
JTE4MNN1MD
AZITHROMYCIN MONOHYDRATE
RxCUI 1298839
Orange Book
A065225
AB
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": "50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387",
"productndc": "50111-787",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "065225",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Nov 14, 2005"
}
],
"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/1",
"application_number": "ANDA065225",
"marketing_category": "ANDA",
"nonproprietary_name": "Azithromycin",
"start_marketing_date": "20060106",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01FA10.
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