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NDC 63323-0318-01 Granisetron 1 mg/mL Details
Granisetron 1 mg/mL
Granisetron 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 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: 63323-0318-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Granisetron Injection
Product Information
| NDC | 63323-0318 |
|---|---|
| Product ID | 63323-318_fd73c3f4-aa7d-4c2f-ab74-1883910ea086 |
| 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 |
| 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 | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078096 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0318-01 (63323031801)
| NDC Package Code | 63323-318-01 |
|---|---|
| Billing NDC | 63323031801 |
| Package | 1 VIAL, SINGLE-USE in 1 BOX (63323-318-01) / 1 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2009-11-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |