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United States · US · US:59651-007_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a
Azithromycin
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159651007151 BOTTLE in 1 CARTON (59651-007-15) / 15 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A209201
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azithromycin Injection
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": "59651-007_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a",
"productndc": "59651-007",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "209201",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE/5ML",
"product_no": "001",
"approval_date": "Oct 9, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE/5ML",
"product_no": "002",
"approval_date": "Oct 9, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZITHROMYCIN DIHYDRATE",
"shortage_reason": "Azithromycin Injection",
"shortage_status": "current",
"proprietary_name": "Azithromycin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA209201",
"marketing_category": "ANDA",
"nonproprietary_name": "Azithromycin",
"start_marketing_date": "20181009",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J01FA10.
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