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United States · US · US:43598-427_8911775c-4f88-acf0-5084-e879da9d1cd4
Decitabine
In shortageOrange BookUNIISPLATC L01BC08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeL01BC08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143598427371 VIAL, SINGLE-USE in 1 CARTON (43598-427-37) / 10 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
776B62CQ27
DECITABINE
RxCUI 15657
Orange Book
A203131
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": "43598-427_8911775c-4f88-acf0-5084-e879da9d1cd4",
"productndc": "43598-427",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "203131",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "50MG/VIAL",
"product_no": "001",
"approval_date": "Jul 11, 2013"
}
],
"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/10mL",
"application_number": "ANDA203131",
"marketing_category": "ANDA",
"nonproprietary_name": "Decitabine",
"start_marketing_date": "20141205",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L01BC08.
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