🇺🇸
United States · US · US:67046-1503_2cc9449e-e4be-3667-e063-6294a90af6ba
azithromycin dihydrate
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoupler LLC
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11670461503330 TABLET in 1 BLISTER PACK (67046-1503-3)
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A065400
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": "67046-1503_2cc9449e-e4be-3667-e063-6294a90af6ba",
"productndc": "67046-1503",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "065400",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 600MG BASE",
"product_no": "001",
"approval_date": "May 15, 2015"
}
],
"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 dihydrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065400",
"marketing_category": "ANDA",
"nonproprietary_name": "azithromycin dihydrate",
"start_marketing_date": "20250128",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J01FA10.
Access this data programmatically
Query azithromycin dihydrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.