Topotecan Hydrochloride is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Topotecan Hydrochloride.
| Product ID | 63323-762_11dbb5b9-c1ad-410b-aea7-cd05239a3645 |
| NDC | 63323-762 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Topotecan Hydrochloride |
| Generic Name | Topotecan Hydrochloride |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2010-11-30 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091089 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | TOPOTECAN HYDROCHLORIDE |
| Active Ingredient Strength | 4 mg/4mL |
| Pharm Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2010-11-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091089 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-11-30 |
| Marketing End Date | 2018-12-26 |
| Marketing Category | ANDA |
| Application Number | ANDA091089 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-11-30 |
| Marketing Category | ANDA |
| Application Number | ANDA091376 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-12-31 |
| Marketing End Date | 2016-03-18 |
| Marketing Category | ANDA |
| Application Number | ANDA091376 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-12-31 |
| Marketing End Date | 2016-03-18 |
| Marketing Category | ANDA |
| Application Number | ANDA091089 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-11-30 |
| Ingredient | Strength |
|---|---|
| TOPOTECAN HYDROCHLORIDE | 4 mg/4mL |
| SPL SET ID: | b6019088-cd94-43b4-b5ce-ba20b6b8021e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 16729-151 | topotecan hydrochloride | topotecan hydrochloride |
| 45963-615 | Topotecan hydrochloride | Topotecan hydrochloride |
| 55390-370 | Topotecan Hydrochloride | Topotecan Hydrochloride |
| 63323-762 | Topotecan Hydrochloride | TOPOTECAN HYDROCHLORIDE |
| 69097-262 | TOPOTECAN HYDROCHLORIDE | TOPOTECAN HYDROCHLORIDE |
| 0078-0674 | HYCAMTIN | topotecan hydrochloride |
| 71288-127 | Topotecan | Topotecan Hydrochloride |