Prescription drug · ANDA
Azacitidine NDC 69539-112
Azacitidine 100 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous, Subcutaneous · MSN LABORATORIES PRIVATE LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69539-112-01 | 69539011201 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (69539-112-01)Marketed from May 18, 2024 |
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)
- Azacitidine
- Generic name (nonproprietary)
- azacitidine
- Active ingredients
- Azacitidine — 100 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212580
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 69539-112_149556cf-d002-4d8b-875b-062561da3f44SPL ID 149556cf-d002-4d8b-875b-062561da3f44SPL set ID d24f1fc5-17c6-4e0c-b852-72692e835cffRxCUI 485246UNII M801H13NRUUPC 0369539112012
- 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
N469539011201followed by a unit qualifier and the quantityPackage 69539-0112-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 212580
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 |
|---|---|---|---|---|
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Sandoz Inc | 0781-3491 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Civica, Inc. | 72572-020 |