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United States · US · US:67296-0020_3ddecd2f-ea4c-536f-e063-6294a90a7936
Zithromax
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRedpharm Drug
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1167296002014 TABLET, FILM COATED in 1 BOTTLE (67296-0020-1)
- ndc1167296002026 TABLET, FILM COATED in 1 BOTTLE (67296-0020-2)
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
N050711
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": {
"db52b91e-79f7-4cc1-9564-f2eee8e31c45": {
"match": "brand_token",
"title": "ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "48",
"published_date": "2026-01-08"
}
},
"productid": "67296-0020_3ddecd2f-ea4c-536f-e063-6294a90a7936",
"productndc": "67296-0020",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "050711",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Jul 18, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZITHROMYCIN DIHYDRATE",
"shortage_reason": "Azithromycin Injection",
"shortage_status": "current",
"proprietary_name": "Zithromax",
"active_ingred_unit": "mg/1",
"application_number": "NDA050711",
"marketing_category": "NDA",
"nonproprietary_name": "azithromycin dihydrate",
"start_marketing_date": "19960718",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01FA10.
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