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United States · US · US:70518-0599_47fa21e2-07c3-16d5-e063-6394a90abf0d
Azithromycin
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170518059902 POUCH in 1 BOX (70518-0599-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-0599-6)
- ndc1170518059932 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-3)
Annotations
UNII (FDA Substance ID)
JTE4MNN1MD
AZITHROMYCIN MONOHYDRATE
RxCUI 1298839
Orange Book
A065223
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": "70518-0599_47fa21e2-07c3-16d5-e063-6394a90abf0d",
"productndc": "70518-0599",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "065223",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG 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": "ANDA065223",
"marketing_category": "ANDA",
"nonproprietary_name": "Azithromycin",
"start_marketing_date": "20170628",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01FA10.
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