Prescription drug · ANDA
Azacitidine NDC 43817-906
Azacitidine 100 mg/50mL · Injection, Powder, Lyophilized, For solution · Subcutaneous · Panacea Biotec Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43817-906-01 | 4381709060143817090601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43817-906-01) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from May 6, 2019 |
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/50mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Subcutaneous
- Labeler
- Panacea Biotec LimitedNDC labeler code 43817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207234
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 43817-906_dcfb97f4-4218-4d97-ba28-4f97dabe4ac0SPL ID dcfb97f4-4218-4d97-ba28-4f97dabe4ac0SPL set ID 9abb489d-ce54-4140-83f6-b756f00b0967RxCUI 485246UNII 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 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
N443817090601followed by a unit qualifier and the quantityPackage 43817-0906-01. 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 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 Myelodysplastic Syndromes (MDS) Azacitidine for injection is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refract…
Excerpt only. Read the full label for complete information.
About NDC 43817-906
- What is NDC 43817-906?
- 43817-906 is the product NDC for Azacitidine, Azacitidine 100 mg/50mL injection, powder, lyophilized, for solution, listed with the FDA by Panacea Biotec Limited. 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?
- Panacea Biotec Limited, NDC labeler code 43817. 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 |