Prescription drug · ANDA
Decitabine NDC 70121-1644
Decitabine 50 mg/20mL · Injection, Powder, Lyophilized, For solution · Intravenous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1644-1 | 70121164401 | 1 VIAL, SINGLE-USE in 1 CARTON (70121-1644-1) / 20 mL in 1 VIAL, SINGLE-USEMarketed from Dec 1, 2019 |
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
- Amneal Pharmaceuticals LLCNDC labeler code 70121
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206033
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 70121-1644_5b9c6cb1-3315-4023-8a3b-9c92596d01f9SPL ID 5b9c6cb1-3315-4023-8a3b-9c92596d01f9SPL set ID 40e7ef72-8df5-4adf-a269-4ae1c26eb6f9RxCUI 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
N470121164401followed by a unit qualifier and the quantityPackage 70121-1644-01. 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 70121-1644
- What is NDC 70121-1644?
- 70121-1644 is the product NDC for Decitabine, Decitabine 50 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by Amneal Pharmaceuticals 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?
- Amneal Pharmaceuticals LLC, NDC labeler code 70121. 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?
- 21 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 | BluePoint Laboratories | 68001-573 | 68001-0573-41 |
| 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 |