Prescription drug · ANDA
Arsenic trioxide NDC 70710-1896
Arsenic trioxide 2 mg/mL · Injection, Solution · Intravenous · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1896-6 | 70710189606 | 10 VIAL in 1 CARTON (70710-1896-6) / 6 mL in 1 VIAL (70710-1896-1)Marketed from Feb 28, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206228
- Marketing start
- Listing expires
- Identifiers
- Product ID 70710-1896_29dd291f-caa8-4ac4-ab3d-d5769be390f2SPL ID 29dd291f-caa8-4ac4-ab3d-d5769be390f2SPL set ID 3e1d2b63-ccb2-4e97-a009-5983eabf65e4RxCUI 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
N470710189606followed by a unit qualifier and the quantityPackage 70710-1896-06. 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: In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. ( 1.1 ) 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 ) 1.1 Newly-Diagnosed Low-Risk APL Arsenic trioxide injection is indicated in combination with tretinoin for treatment of adults with newly-di…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206228
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 | Zydus Pharmaceuticals USA Inc. | 70710-1895 |
| Arsenic trioxide | Arsenic trioxide 2 mg/mL | Injection, SolutionIntravenous | Zydus Lifesciences Limited | 49315-007 |
| Arsenic trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Zydus Lifesciences Limited | 49315-005 |
| Arsenic trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Zydus Pharmaceuticals USA Inc. | 68382-997 |
| Arsenic trioxide | Arsenic trioxide 2 mg/mL | Injection, SolutionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-1610 |