Prescription drug · ANDA
Arsenic trioxide NDC 49315-007
Arsenic trioxide 2 mg/mL · Injection, Solution · Intravenous · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49315-007-10 | 4931500071049315000710 | 10 VIAL in 1 CARTON (49315-007-10) / 6 mL in 1 VIAL (49315-007-01)Marketed from Sep 3, 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)
- Arsenic trioxide
- Generic name (nonproprietary)
- arsenic trioxide
- Active ingredients
- Arsenic trioxide — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 49315
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206228
- Marketing start
- Listing expires
- Identifiers
- Product ID 49315-007_e80b0973-e6e5-4914-b5f0-4528d7fa7285SPL ID e80b0973-e6e5-4914-b5f0-4528d7fa7285SPL set ID 2ad7bb19-6152-4158-a179-2388e86a981fRxCUI 1992545UNII S7V92P67HOUPC 0349315007107, 0349315007015
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
N449315000710followed by a unit qualifier and the quantityPackage 49315-0007-10. 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 .
About NDC 49315-007
- What is NDC 49315-007?
- 49315-007 is the product NDC for Arsenic trioxide, Arsenic trioxide 2 mg/mL injection, solution, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, 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?
- Zydus Lifesciences Limited, NDC labeler code 49315. 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 |
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 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 |
| 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 Pharmaceuticals USA Inc. | 70710-1896 |