Prescription drug · ANDA
Azacitidine NDC 63323-771
Azacitidine 100 mg/30mL · Injection, Powder, Lyophilized, For solution · Intravenous, Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-771-39 | 63323077139 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-771-39) / 30 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 16, 2017 |
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/30mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207518
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 63323-771_4becda8d-8042-4cf1-bef3-c0ec3c23eebeSPL ID 4becda8d-8042-4cf1-bef3-c0ec3c23eebeSPL set ID 3b594aba-e798-4105-b801-0b0d970747c1RxCUI 485246UNII M801H13NRUUPC 0363323771393
- 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
N463323077139followed by a unit qualifier and the quantityPackage 63323-0771-39. 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)
Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: • Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). ( 1.1 ) 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207518
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 |
|---|---|---|---|---|
| Azacitidineazacitidine for | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Pilnova Pharma Inc | 83774-102 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Armas Pharmaceuticals Inc. | 72485-201 |
| Azacitidine Azacitidineazacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Dr. Reddy's Laboratories Inc. | 43598-678 |