Prescription drug · NDA
Onureg (azacitidine) NDC 59572-730
Azacitidine 200 mg/1 · Tablet, Film coated · Oral · Celgene Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59572-730-07 | 59572073007 | 7 TABLET, FILM COATED in 1 BLISTER PACK (59572-730-07)Marketed from Dec 18, 2020 |
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)
- Onureg
- Generic name (nonproprietary)
- azacitidine
- Active ingredients
- Azacitidine — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Celgene Corporation
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214120
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 59572-730_1b026a12-462b-40f3-81d8-099c1b111718SPL ID 1b026a12-462b-40f3-81d8-099c1b111718SPL set ID 0e95e33f-8aba-4f19-b332-2416580d358bRxCUI 2396764, 2396770, 2396772, 2396774UNII M801H13NRU
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459572073007followed by a unit qualifier and the quantityPackage 59572-0730-07. 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)
ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 214120
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 |
|---|---|---|---|---|
| Onuregazacitidine | Azacitidine 300 mg/1 | Tablet, Film coatedOral | Celgene Corporation | 59572-740 |