🇺🇸
United States · US · US:83008-081_ba400da0-efae-451a-91d4-b9f5ad4dc773
Azithromycin Dihydrate
In shortageOrange BookUNIISPLATC J01FA10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQuality Care Products, LLC
CountryUS (United States)
ATC codeJ01FA10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183008081061 BLISTER PACK in 1 CARTON (83008-081-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A208250
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azithromycin Tablet
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": "83008-081_ba400da0-efae-451a-91d4-b9f5ad4dc773",
"productndc": "83008-081",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208250",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Apr 17, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZITHROMYCIN DIHYDRATE",
"shortage_reason": "Azithromycin Tablet",
"shortage_status": "current",
"proprietary_name": "Azithromycin Dihydrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208250",
"marketing_category": "ANDA",
"nonproprietary_name": "Azithromycin Dihydrate",
"start_marketing_date": "20240828",
"active_numerator_strength": "250"
}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.