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 |