🇺🇸
United States · US · US:16729-224_1cd33ab4-5938-ce87-e063-6394a90a7880
Decitabine
In shortageOrange BookUNIISPLATC L01BC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeL01BC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1116729224051 VIAL in 1 CARTON (16729-224-05) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
776B62CQ27
DECITABINE
RxCUI 15657
Orange Book
A203475
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Decitabine Injection
Raw payload (JSON)
{
"unii": {
"unii": "776B62CQ27",
"rxcui": "15657",
"inchikey": "XAUDJQYHKZQPEU-KVQBGUIXSA-N",
"display_name": "DECITABINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"8c5d6067-16a1-43ab-9e52-a33c600a5c44": {
"match": "brand_token",
"title": "DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
"spl_version": "3",
"published_date": "2026-05-28"
}
},
"productid": "16729-224_1cd33ab4-5938-ce87-e063-6394a90a7880",
"productndc": "16729-224",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "203475",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/VIAL",
"product_no": "001",
"approval_date": "Feb 27, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DECITABINE",
"shortage_reason": "Decitabine Injection",
"shortage_status": "current",
"proprietary_name": "Decitabine",
"active_ingred_unit": "mg/20mL",
"application_number": "ANDA203475",
"marketing_category": "ANDA",
"nonproprietary_name": "decitabine",
"start_marketing_date": "20170308",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01BC08.
Access this data programmatically
Query Decitabine 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.