Palonosetron is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Palonosetron Hydrochloride.
| Product ID | 63323-942_61109020-f621-4aba-9578-74f156bfc5f0 |
| NDC | 63323-942 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Palonosetron |
| Generic Name | Palonosetron |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2017-06-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208109 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | PALONOSETRON HYDROCHLORIDE |
| Active Ingredient Strength | 0 mg/5mL |
| Pharm Classes | Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2017-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA208109 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-06-01 |
| Marketing End Date | 2020-02-29 |
| Marketing Category | NDA |
| Application Number | NDA208109 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-06-01 |
| Marketing End Date | 2020-02-29 |
| Marketing Category | NDA |
| Application Number | NDA208109 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-06-01 |
| Marketing End Date | 2020-02-29 |
| Marketing Category | NDA |
| Application Number | NDA208109 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-06-01 |
| Marketing End Date | 2020-02-29 |
| Ingredient | Strength |
|---|---|
| PALONOSETRON HYDROCHLORIDE | .25 mg/5mL |
| SPL SET ID: | 65a657b8-f9d4-4a80-8ce5-d6e58b59b916 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 16714-834 | Palonosetron | Palonosetron |
| 55111-694 | Palonosetron | Palonosetron |
| 60505-6193 | Palonosetron | Palonosetron Hydrochloride |
| 63323-673 | Palonosetron | Palonosetron |
| 63323-942 | Palonosetron | Palonosetron |
| 67184-0514 | Palonosetron | Palonosetron Hydrochloride |
| 67184-0515 | Palonosetron | Palonosetron Hydrochloride |
| 68001-355 | Palonosetron | Palonosetron |
| 68001-482 | Palonosetron | Palonosetron Hydrochloride |