Prescription drug · ANDA
Decitabine NDC 55150-376
Decitabine 50 mg/26mL · Injection, Powder, Lyophilized, For solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-376-01 | 5515003760155150037601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-376-01) / 26 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 20, 2021 |
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
- Active ingredients
- Decitabine — 50 mg/26mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214569
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 55150-376_2c794637-f383-49c6-9f3d-6bcc25e79e66SPL ID 2c794637-f383-49c6-9f3d-6bcc25e79e66SPL set ID a99f92cf-88f9-469b-aa69-44831e0bd4abRxCUI 636631UNII 776B62CQ27UPC 0355150376018
- 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.
- NDC on a medical claim
N455150037601followed by a unit qualifier and the quantityPackage 55150-0376-01. 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 .
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.
About NDC 55150-376
- What is NDC 55150-376?
- 55150-376 is the product NDC for Decitabine, Decitabine 50 mg/26mL injection, powder, lyophilized, for solution, listed with the FDA by Eugia US LLC. 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?
- Eugia US LLC, NDC labeler code 55150. 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.
Related NDCs: other Decitabine products
Other finished products listed under the same name: strengths, forms and labelers.
| 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/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 |
| decitabine | Decitabine 50 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-528 | 68083-0528-01 |