Prescription drug · ANDA
Arsenic Trioxide NDC 0781-3498
Arsenic trioxide 2 mg/mL · Injection, Solution · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3498-94 | 00781349894 | 1 VIAL in 1 CARTON (0781-3498-94) / 6 mL in 1 VIALMarketed from May 19, 2022 | |
| 0781-3498-95 | 00781349895 | 10 VIAL in 1 CARTON (0781-3498-95) / 6 mL in 1 VIAL (0781-3498-06)Marketed from May 19, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215359
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-3498_601a01b0-da7f-4b9d-9f66-bc67371a1268SPL ID 601a01b0-da7f-4b9d-9f66-bc67371a1268SPL set ID a9008658-c2dd-49f4-b1c4-26e232c81957RxCUI 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
N400781349894followed by a unit qualifier and the quantityPackage 00781-3498-94. 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 acute promyelocytic leukemia (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.
About NDC 0781-3498
- What is NDC 0781-3498?
- 0781-3498 is the product NDC for Arsenic Trioxide, Arsenic trioxide 2 mg/mL injection, solution, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arsenic Trioxide.
- What is the active ingredient?
- Arsenic trioxide.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arsenic Trioxide?
- 26 other product NDCs are listed under this name. See all Arsenic Trioxide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Arsenic Trioxide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Arsenic Trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Sintetica US LLC | 83090-009 | 83090-0009-0183090-0009-10 |
| Arsenic Trioxide | Arsenic trioxide 2 mg/mL | Injection, SolutionIntravenous | Sintetica US LLC | 83090-010 | 83090-0010-0183090-0010-10 |
| Arsenic Trioxide | Arsenic trioxide 1 mg/mL | InjectionIntravenous | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc | 23155-869 | 23155-0869-41 |
| Arsenic Trioxide | Arsenic trioxide 2 mg/mL | InjectionIntravenous | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc | 23155-870 | 23155-0870-41 |
| Arsenic Trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Orbicular Pharmaceutical Technologies Private Limited | 81607-005 | 81607-0005-11 |
| Arsenic Trioxide | Arsenic trioxide 2 mg/mL | Injection, SolutionIntravenous | Orbicular Pharmaceutical Technologies Private Limited | 81607-006 | 81607-0006-07 |
| Arsenic Trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-171 | 72205-0171-07 |
| Arsenic Trioxide | Arsenic trioxide 2 mg/2mL | Injection, SolutionIntravenous | Novadoz Pharmaceuticals LLC | 72205-172 | 72205-0172-07 |
| Arsenic Trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Northstar Rx LLC | 72603-339 | 72603-0339-10 |
| Arsenic trioxide | Arsenic trioxide 1 mg/mL | Injection, SolutionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-1895 | 70710-1895-06 |