decitabine

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4733536141
1 KIT in 1 CARTON (47335-361-41) * 10 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL (47335-362-40)

Annotations

Orange Book

N205582

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "47335-361_ddc155a1-509c-4d7e-bab1-fa5891ef354e",
  "productndc": "47335-361",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205582",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Jan 28, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "decitabine",
  "active_ingred_unit": null,
  "application_number": "NDA205582",
  "marketing_category": "NDA",
  "nonproprietary_name": "decitabine",
  "start_marketing_date": "20140124",
  "active_numerator_strength": null
}

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.

Get a free API key Read the API docs