Prescription drug · ANDA
Arsenic Trioxide NDC 83090-009
Arsenic trioxide 1 mg/mL · Injection, Solution · Intravenous · Sintetica US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83090-009-01 | 83090000901 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-009-01) / 10 mL in 1 VIAL, SINGLE-DOSE (83090-009-05)Marketed from Nov 9, 2023 | |
| 83090-009-10 | 83090000910 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83090-009-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83090-009-05)Marketed from Nov 9, 2023 |
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)
- Arsenic Trioxide
- Generic name (nonproprietary)
- arsenic trioxide
- Active ingredients
- Arsenic trioxide — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sintetica US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217413
- Marketing start
- Listing expires
- Identifiers
- Product ID 83090-009_d95da146-99a2-491f-be7e-28e5fd86928fSPL ID d95da146-99a2-491f-be7e-28e5fd86928fSPL set ID d921f52f-2f38-4300-ae40-31f00b3a500aRxCUI 829926, 1992545UNII S7V92P67HO
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
N483090000901followed by a unit qualifier and the quantityPackage 83090-0009-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Arsenic trioxide injection is an arsenical indicated: For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. ( 1.2 ) 1.2 Relapsed or Refractory APL Arsenic trioxide injection is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217413
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 |
|---|---|---|---|---|
| Arsenic Trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Northstar Rx LLC | 72603-339 |
| Arsenic Trioxide | Arsenic trioxide 2 mg/mL | Injection, SolutionIntravenous | Sintetica US LLC | 83090-010 |
| Arsenic Trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Orbicular Pharmaceutical Technologies Private Limited | 81607-005 |
| Arsenic Trioxide | Arsenic trioxide 2 mg/mL | Injection, SolutionIntravenous | Orbicular Pharmaceutical Technologies Private Limited | 81607-006 |
| Arsenic Trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-171 |
| Arsenic Trioxide | Arsenic trioxide 2 mg/2mL | Injection, SolutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-172 |