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NDC 67457-0863-01 Granisetron Hydrochloride 1 mg/mL Details
Granisetron Hydrochloride 1 mg/mL
Granisetron Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is GRANISETRON HYDROCHLORIDE.
MedlinePlus Drug Summary
Granisetron immediate-release injection is used to prevent nausea and vomiting caused by cancer chemotherapy and to prevent and treat nausea and vomiting that may occur after surgery. Granisetron extended-release (long-acting) injection is used with other medications to prevent nausea and vomiting caused by cancer chemotherapy that may occur immediately or several days after receiving chemotherapy medications. Granisetron is in a class of medications called 5-HT3 receptor antagonists. It works by blocking serotonin, a natural substance in the body that causes nausea and vomiting.
Related Packages: 67457-0863-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Granisetron Injection
Product Information
| NDC | 67457-0863 |
|---|---|
| Product ID | 67457-863_745f7893-7d47-4fad-9341-93310622013c |
| Associated GPIs | 50250035102010 |
| GCN Sequence Number | 063538 |
| GCN Sequence Number Description | granisetron HCl/PF VIAL 1 MG/ML(1) INTRAVEN |
| HIC3 | H6J |
| HIC3 Description | ANTIEMETIC/ANTIVERTIGO AGENTS |
| GCN | 99260 |
| HICL Sequence Number | 034765 |
| HICL Sequence Number Description | GRANISETRON HCL/PF |
| Brand/Generic | Generic |
| Proprietary Name | Granisetron Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Granisetron Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | GRANISETRON HYDROCHLORIDE |
| Labeler Name | Mylan Institutional LLC |
| Pharmaceutical Class | Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091136 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 67457-0863-01 (67457086301)
| NDC Package Code | 67457-863-01 |
|---|---|
| Billing NDC | 67457086301 |
| Package | 1 VIAL in 1 CARTON (67457-863-01) / 1 mL in 1 VIAL |
| Marketing Start Date | 2018-03-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |