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United States · US · US:63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc
Azithromycin
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11631870931515 mL in 1 BOTTLE (63187-093-15)
- ndc11631870932222.5 mL in 1 BOTTLE (63187-093-22)
- ndc11631870933030 mL in 1 BOTTLE (63187-093-30)
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": "63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc",
"productndc": "63187-093",
"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": "20101217",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J01FA10.
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