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United States · US · US:50090-4458_57c5f28a-3308-4eb6-ae6d-9e911f1f6989
Azithromycin
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150090445801 BOTTLE in 1 CARTON (50090-4458-0) / 30 mL in 1 BOTTLE
- ndc11500904458130 CASE in 1 BOTTLE (50090-4458-1) / 24 mL in 1 CASE
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A211147
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": "50090-4458_57c5f28a-3308-4eb6-ae6d-9e911f1f6989",
"productndc": "50090-4458",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "211147",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE/5ML",
"product_no": "001",
"approval_date": "Jul 31, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 200MG BASE/5ML",
"product_no": "002",
"approval_date": "Jul 31, 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": "ANDA211147",
"marketing_category": "ANDA",
"nonproprietary_name": "Azithromycin",
"start_marketing_date": "20180806",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J01FA10.
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