Prescription drug · NDA
decitabine NDC 47335-361
Kit · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-361-41 | 47335036141 | 1 KIT in 1 CARTON (47335-361-41) * 10 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL (47335-362-40)Marketed from Jan 24, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- decitabine
- Generic name (nonproprietary)
- decitabine
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205582
- Marketing start
- Listing expires
- Identifiers
- Product ID 47335-361_ddc155a1-509c-4d7e-bab1-fa5891ef354eSPL ID ddc155a1-509c-4d7e-bab1-fa5891ef354eSPL set ID c155d6ba-9a16-406c-919e-65a149689ab9RxCUI 636631
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N447335036141followed by a unit qualifier and the quantityPackage 47335-0361-41. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de nov…
Excerpt only. Read the full label for complete information.