Prescription drug · ANDA
Decitabine NDC 72162-2634
Decitabine 50 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2634-2 | 72162263402 | 1 VIAL, SINGLE-USE in 1 CARTON (72162-2634-2) / 20 mL in 1 VIAL, SINGLE-USEMarketed from May 6, 2026 |
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/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212265
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 72162-2634_65cf8205-fdd2-4b24-ab56-ffd03eca0ae2SPL ID 65cf8205-fdd2-4b24-ab56-ffd03eca0ae2SPL set ID c731a9f0-46ee-41c3-8f89-179cab13bdd2RxCUI 636631UNII 776B62CQ27
- 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
N472162263402followed by a unit qualifier and the quantityPackage 72162-2634-02. 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.
Other NDCs under ANDA 212265
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Decitabine | Decitabine 50 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-031 |
| Decitabine | Decitabine 50 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Northstar Rx LLC | 72603-107 |
| Decitabine | Decitabine 50 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-036 |
| Decitabine | Decitabine 50 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | BluePoint Laboratories | 68001-713 |