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United States · US · US:70518-4367_3ff1f6a7-77d5-1da0-e063-6294a90a2099
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 · 3
- ndc11705184367030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4367-0)
- ndc1170518436712 POUCH in 1 BOX (70518-4367-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-4367-2)
- ndc1170518436732 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4367-3)
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A065399
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": "70518-4367_3ff1f6a7-77d5-1da0-e063-6294a90a2099",
"productndc": "70518-4367",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "065399",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 500MG BASE",
"product_no": "001",
"approval_date": "May 15, 2015"
}
],
"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": "ANDA065399",
"marketing_category": "ANDA",
"nonproprietary_name": "azithromycin",
"start_marketing_date": "20250620",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01FA10.
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