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NDC 69097-0439-35 Palonosetron hydrochloride 0.25 mg/5mL Details
Palonosetron hydrochloride 0.25 mg/5mL
Palonosetron hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA Inc.. The primary component is PALONOSETRON HYDROCHLORIDE.
MedlinePlus Drug Summary
Palonosetron injection is used to prevent nausea and vomiting that may occur within 24 hours after receiving cancer chemotherapy or surgery. It is also used to prevent delayed nausea and vomiting that may occur several days after receiving certain chemotherapy medications. Palonosetron injection is in a class of medications called 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.
Related Packages: 69097-0439-35Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Palonosetron Injection
Product Information
| NDC | 69097-0439 |
|---|---|
| Product ID | 69097-439_b4ddbb13-5b11-40b1-b126-dc2d1b44c9dd |
| Associated GPIs | 50250070102020 |
| GCN Sequence Number | 052943 |
| GCN Sequence Number Description | palonosetron HCl VIAL 0.25MG/5ML INTRAVEN |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 20228 |
| HICL Sequence Number | 025512 |
| HICL Sequence Number Description | PALONOSETRON HCL |
| Brand/Generic | Generic |
| Proprietary Name | Palonosetron hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Palonsetron hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 0.25 |
| Active Ingredient Units | mg/5mL |
| Substance Name | PALONOSETRON HYDROCHLORIDE |
| Labeler Name | Cipla USA Inc. |
| Pharmaceutical Class | Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206396 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69097-0439-35 (69097043935)
| NDC Package Code | 69097-439-35 |
|---|---|
| Billing NDC | 69097043935 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (69097-439-35) / 5 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2021-10-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |