What is NDC 67184-0535?

67184-0535 is the product NDC for Decitabine, Decitabine 50 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. 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 67184-0535 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67184-0535Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67184-0535Add 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
67184-0535-1	6718405350167184053501	1 VIAL in 1 CARTON (67184-0535-1) / 20 mL in 1 VIALMarketed from Apr 12, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Active ingredients: Decitabine — 50 mg/20mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212826
Marketing start: Apr 12, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 67184-0535_0afb3dc7-6072-4a53-acc4-59589fb8491eSPL ID 0afb3dc7-6072-4a53-acc4-59589fb8491eSPL set ID 5b2dce6f-c715-47dc-971e-06244ccd7548RxCUI 636631UNII 776B62CQ27UPC 0367184053513
Pharmacologic class: Nucleoside Metabolic Inhibitor

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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N467184053501 followed by a unit qualifier and the quantity

Package 67184-0535-01. 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 Oct 18, 2021.

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 67184-0535

What is NDC 67184-0535?: 67184-0535 is the product NDC for Decitabine, Decitabine 50 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Decitabine.
What is the active ingredient?: Decitabine.
Who is the labeler?: Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. 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	Nivagen Pharmaceuticals, Inc.	75834-190	75834-0190-01
decitabine	Decitabine 50 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Gland Pharma Limited	68083-528	68083-0528-01

All 21 Decitabine NDCs

Other NDCs under ANDA 212826

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212826
Product	Strength	Form · route	Labeler	Product NDC
Decitabine	Decitabine 50 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-219
Decitabine	Decitabine 50 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	BluePoint Laboratories	68001-618