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NDC 68382-0997-10 Arsenic trioxide 1 mg/mL Details
Arsenic trioxide 1 mg/mL
Arsenic trioxide is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is ARSENIC TRIOXIDE.
MedlinePlus Drug Summary
Arsenic trioxide is used in combination with tretinoin to treat acute promyelocytic leukemia (APL; a type of cancer in which there are too many immature blood cells in the blood and bone marrow) in certain people as a first treatment. It is also used to treat APL in certain people who have not been helped by other types of chemotherapy or whose condition has improved but then worsened following treatment with a retinoid and other types of chemotherapy treatment(s). Arsenic trioxide is in a class of medications called anti-neoplastics. It works by slowing or stopping the growth of cancer cells.
Related Packages: 68382-0997-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Arsenic Trioxide Injection
Product Information
| NDC | 68382-0997 |
|---|---|
| Product ID | 68382-997_11b2ed41-29fc-4198-8d2e-1c353893fd8f |
| Associated GPIs | 21700008102020 |
| GCN Sequence Number | 053975 |
| GCN Sequence Number Description | arsenic trioxide VIAL 10 MG/10ML INTRAVEN |
| HIC3 | V1F |
| HIC3 Description | ANTINEOPLASTICS,MISCELLANEOUS |
| GCN | 21764 |
| HICL Sequence Number | 021734 |
| HICL Sequence Number Description | ARSENIC TRIOXIDE |
| Brand/Generic | Generic |
| Proprietary Name | Arsenic trioxide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Arsenic trioxide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | ARSENIC TRIOXIDE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206228 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0997-10 (68382099710)
| NDC Package Code | 68382-997-10 |
|---|---|
| Billing NDC | 68382099710 |
| Package | 10 VIAL in 1 CARTON (68382-997-10) / 10 mL in 1 VIAL (68382-997-01) |
| Marketing Start Date | 2018-11-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |