Topotecan is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Topotecan Hydrochloride.
| Product ID | 0409-0302_293334d4-88f2-4ec2-9eed-20975ff65c0a |
| NDC | 0409-0302 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Topotecan |
| Generic Name | Topotecan |
| Dosage Form | Injection, Solution, Concentrate |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2011-02-21 |
| Marketing Category | NDA / NDA |
| Application Number | NDA200582 |
| Labeler Name | Hospira, Inc. |
| Substance Name | TOPOTECAN HYDROCHLORIDE |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2011-02-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA200582 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-02-21 |
| Marketing Category | NDA |
| Application Number | NDA200582 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-09-24 |
| Marketing End Date | 2018-01-31 |
| Ingredient | Strength |
|---|---|
| TOPOTECAN HYDROCHLORIDE | 1 mg/mL |
| SPL SET ID: | 1d4e1cce-c57e-4a8b-be96-f95a2778e221 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-0302 | Topotecan | TOPOTECAN |
| 0703-4714 | Topotecan | Topotecan |
| 16729-243 | Topotecan | Topotecan |
| 25021-236 | topotecan | topotecan |
| 50742-404 | Topotecan | Topotecan |
| 66758-051 | Topotecan | Topotecan |
| 67457-662 | TOPOTECAN | TOPOTECAN |
| 71288-127 | Topotecan | Topotecan Hydrochloride |
| 0078-0672 | HYCAMTIN | topotecan |
| 0078-0673 | HYCAMTIN | topotecan |