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United States · US · US:65862-641_db155bb5-7adc-494a-be66-a2e8e4a45fe1
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 · 6
- ndc116586264101100 TABLET, FILM COATED in 1 BOTTLE (65862-641-01)
- ndc116586264105500 TABLET, FILM COATED in 1 BOTTLE (65862-641-05)
- ndc11658626413030 TABLET, FILM COATED in 1 BOTTLE (65862-641-30)
- ndc11658626415050 TABLET, FILM COATED in 1 BOTTLE (65862-641-50)
- ndc1165862641633 BLISTER PACK in 1 CARTON (65862-641-63) / 6 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1165862641691 BLISTER PACK in 1 CARTON (65862-641-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A207370
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": "65862-641_db155bb5-7adc-494a-be66-a2e8e4a45fe1",
"productndc": "65862-641",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207370",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Jul 5, 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/1",
"application_number": "ANDA207370",
"marketing_category": "ANDA",
"nonproprietary_name": "Azithromycin",
"start_marketing_date": "20180705",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01FA10.
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