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United States · US · US:82584-307_1e292167-581f-b1db-e063-6394a90ae8a1
AZASITE
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerThea Pharma Inc.
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1182584307021 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPER
- ndc1182584307031 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
JTE4MNN1MD
AZITHROMYCIN MONOHYDRATE
RxCUI 1298839
Orange Book
N050810
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azithromycin Tablet
Raw payload (JSON)
{
"unii": {
"unii": "JTE4MNN1MD",
"rxcui": "1298839",
"inchikey": "HQUPLSLYZHKKQT-WVVFQGGUSA-N",
"display_name": "AZITHROMYCIN MONOHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"0c5d6f5e-18ea-436f-8c62-bbaf66effe3d": {
"match": "brand_token",
"title": "AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [THEA PHARMA INC.]",
"spl_version": "4",
"published_date": "2024-07-30"
}
},
"productid": "82584-307_1e292167-581f-b1db-e063-6394a90ae8a1",
"productndc": "82584-307",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "050810",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Apr 27, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZITHROMYCIN MONOHYDRATE",
"shortage_reason": "Azithromycin Tablet",
"shortage_status": "current",
"proprietary_name": "AZASITE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA050810",
"marketing_category": "NDA",
"nonproprietary_name": "azithromycin monohydrate",
"start_marketing_date": "20221101",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code J01FA10.
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