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United States · US · US:70069-857_3bc4f406-2e98-7169-e063-6394a90a81d9
Azacitidine
In shortageOrange BookUNIISPLATC L01BC07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics LLC
CountryUS (United States)
ATC codeL01BC07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170069857011 VIAL, GLASS in 1 CARTON (70069-857-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
M801H13NRU
AZACITIDINE
RxCUI 1251
Orange Book
A217453
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": "70069-857_3bc4f406-2e98-7169-e063-6394a90a81d9",
"productndc": "70069-857",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "217453",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/VIAL",
"product_no": "001",
"approval_date": "May 20, 2025"
}
],
"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/1",
"application_number": "ANDA217453",
"marketing_category": "ANDA",
"nonproprietary_name": "Azacitidine",
"start_marketing_date": "20250829",
"active_numerator_strength": "100"
}Related drugs
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