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United States · US · US:43598-305_35e92030-ae2f-04b2-c3de-69f8c8da6b82
Azacitidine
In shortageOrange BookUNIISPLATC L01BC07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeL01BC07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143598305621 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (43598-305-62)
Annotations
UNII (FDA Substance ID)
M801H13NRU
AZACITIDINE
RxCUI 1251
Orange Book
A201537
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": "43598-305_35e92030-ae2f-04b2-c3de-69f8c8da6b82",
"productndc": "43598-305",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "201537",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/VIAL",
"product_no": "001",
"approval_date": "Sep 16, 2013"
}
],
"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": "ANDA201537",
"marketing_category": "ANDA",
"nonproprietary_name": "Azacitidine",
"start_marketing_date": "20130919",
"active_numerator_strength": "100"
}Related drugs
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