What is NDC 47335-361?

47335-361 is the product NDC for decitabine kit, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for decitabine?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

decitabine NDC 47335-361 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-361Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0361Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
47335-361-41	4733503614147335036141	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
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205582
Marketing start: Jan 24, 2014
Listing expires: Dec 31, 2026
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

N447335036141 followed by a unit qualifier and the quantity

Package 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 Jul 23, 2020.

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.

Full label on DailyMed (opens in a new tab)

About NDC 47335-361

What is NDC 47335-361?: 47335-361 is the product NDC for decitabine kit, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: decitabine.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for decitabine?: 20 other product NDCs are listed under this name. See all decitabine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other decitabine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Decitabine	Decitabine 50 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	BluePoint Laboratories	68001-713	68001-0713-37
Decitabine	Decitabine 50 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	BluePoint Laboratories	68001-642	68001-0642-41
Decitabine	Decitabine 50 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Camber Pharmaceuticals, Inc.	31722-304	31722-0304-31
Decitabine	Decitabine 50 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	BluePoint Laboratories	68001-618	68001-0618-37
Decitabine	Decitabine 50 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-219	25021-0219-20
decitabine	Decitabine 50 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9385	00143-9385-01
Decitabine	Decitabine 50 mg/26mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-376	55150-0376-01
Decitabine	Decitabine 50 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-119	71288-0119-20
Decitabine	Decitabine 50 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Qilu Pharmaceutical Co., Ltd.	67184-0535	67184-0535-01
Decitabine	Decitabine 50 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Nivagen Pharmaceuticals, Inc.	75834-190	75834-0190-01

All 21 decitabine NDCs