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United States · US · US:46708-057_bb31fbb2-b157-4333-ac3b-5f3d65039890
Azithromycin
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11467080570618 BLISTER PACK in 1 CARTON (46708-057-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11467080571818 BLISTER PACK in 1 CARTON (46708-057-18) / 6 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11467080573030 TABLET, FILM COATED in 1 BOTTLE (46708-057-30)
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A211791
AB
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": "46708-057_bb31fbb2-b157-4333-ac3b-5f3d65039890",
"productndc": "46708-057",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211791",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Jan 28, 2020"
}
],
"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/1",
"application_number": "ANDA211791",
"marketing_category": "ANDA",
"nonproprietary_name": "Azithromycin",
"start_marketing_date": "20200129",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01FA10.
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