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United States · US · US:55150-393_e89b9510-86df-4095-b6d3-4eb05b613c4f
AZACITIDINE
In shortageOrange BookUNIISPLATC L01BC07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeL01BC07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155150393011 VIAL, SINGLE-DOSE in 1 CARTON (55150-393-01) / 4 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
M801H13NRU
AZACITIDINE
RxCUI 1251
Orange Book
A215066
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azacitidine Injection
Raw payload (JSON)
{
"unii": {
"unii": "M801H13NRU",
"rxcui": "1251",
"inchikey": "NMUSYJAQQFHJEW-KVTDHHQDSA-N",
"display_name": "AZACITIDINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS; SUBCUTANEOUS",
"spl_meta": {
"cd9db533-8a49-4d01-99e2-b2db8db1ed38": {
"match": "brand_token",
"title": "AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES.]",
"spl_version": "3",
"published_date": "2026-03-30"
}
},
"productid": "55150-393_e89b9510-86df-4095-b6d3-4eb05b613c4f",
"productndc": "55150-393",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "215066",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/VIAL",
"product_no": "001",
"approval_date": "Dec 30, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AZACITIDINE",
"shortage_reason": "Azacitidine Injection",
"shortage_status": "current",
"proprietary_name": "AZACITIDINE",
"active_ingred_unit": "mg/4mL",
"application_number": "ANDA215066",
"marketing_category": "ANDA",
"nonproprietary_name": "AZACITIDINE",
"start_marketing_date": "20230103",
"active_numerator_strength": "100"
}Related drugs
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- DKAzacitidin "Lotus Pharma Bulgaria"Lotus Pharma Bulgaria EOOD
- DKAzacitidin "Stada Arzneimittel AG"STADA Arzneimittel AG
Access this data programmatically
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