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NDC 63323-0315-94 Ganciclovir 500 mg/10mL Details
Ganciclovir 500 mg/10mL
Ganciclovir 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 GANCICLOVIR SODIUM.
MedlinePlus Drug Summary
Ganciclovir injection is used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people whose immune system is not working normally, including those people who have acquired immunodeficiency syndrome (AIDS). It is also used to prevent CMV disease in transplant recipients at risk for CMV infection. Ganciclovir injection is in a class of medications called antivirals. It works by stopping the spread of CMV in the body.
Related Packages: 63323-0315-94Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ganciclovir Injection
Product Information
| NDC | 63323-0315 |
|---|---|
| Product ID | 63323-315_6a576726-9413-47b3-aa25-145102205642 |
| Associated GPIs | 12200030102110 |
| GCN Sequence Number | 011753 |
| GCN Sequence Number Description | ganciclovir sodium VIAL 500 MG INTRAVEN |
| HIC3 | W5A |
| HIC3 Description | ANTIVIRALS, GENERAL |
| GCN | 44620 |
| HICL Sequence Number | 004558 |
| HICL Sequence Number Description | GANCICLOVIR SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Ganciclovir |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | GANCICLOVIR SODIUM |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/10mL |
| Substance Name | GANCICLOVIR SODIUM |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090658 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0315-94 (63323031594)
| NDC Package Code | 63323-315-94 |
|---|---|
| Billing NDC | 63323031594 |
| Package | 25 VIAL in 1 TRAY (63323-315-94) / 10 mL in 1 VIAL (63323-315-41) |
| Marketing Start Date | 2010-06-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |