Prescription drug · ANDA
Azacitidine NDC 72485-201
Azacitidine 100 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous, Subcutaneous · Armas Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-201-01 | 7248502010172485020101 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (72485-201-01)Marketed from Sep 10, 2018 |
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
- Labeler
- Armas Pharmaceuticals Inc.NDC labeler code 72485
- 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 72485-201_ca345575-17a6-43a3-aa02-3d4bb9d136c5SPL ID ca345575-17a6-43a3-aa02-3d4bb9d136c5SPL set ID 5c0a2d5f-8c34-4c04-8425-7543965cedd4RxCUI 485246UNII M801H13NRUUPC 0372485201013
- 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
N472485020101followed by a unit qualifier and the quantityPackage 72485-0201-01. 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)
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 anemia (R…
Excerpt only. Read the full label for complete information.
About NDC 72485-201
- What is NDC 72485-201?
- 72485-201 is the product NDC for Azacitidine, Azacitidine 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Armas Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azacitidine.
- What is the active ingredient?
- Azacitidine.
- Who is the labeler?
- Armas Pharmaceuticals Inc., NDC labeler code 72485. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Azacitidine?
- 22 other product NDCs are listed under this name. See all Azacitidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azacitidine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Somerset Therapeutics LLC | 70069-857 | 70069-0857-01 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Reliance Life Sciences Private Limited | 58458-002 | 58458-0002-02 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Dr. Reddy's Laboratories Inc. | 75907-225 | 75907-0225-11 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | BluePoint Laboratories. | 68001-620 | 68001-0620-54 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Camber Pharmaceuticals, Inc. | 31722-365 | 31722-0365-31 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Sandoz Inc | 0781-3491 | 00781-3491-94 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | MSN LABORATORIES PRIVATE LIMITED | 69539-112 | 69539-0112-01 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Civica, Inc. | 72572-020 | 72572-0020-01 |
| Azacitidineazacitidine for | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Pilnova Pharma Inc | 83774-102 | 83774-0102-01 |
| Azacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Apotex Corp | 60505-6271 | 60505-6271-01 |
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 |
|---|---|---|---|---|
| Azacitidine | Azacitidine 100 mg/30mL | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Fresenius Kabi USA, LLC | 63323-771 |
| Azacitidineazacitidine for | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Pilnova Pharma Inc | 83774-102 |
| Azacitidine Azacitidineazacitidine | Azacitidine 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous | Dr. Reddy's Laboratories Inc. | 43598-678 |