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NDC 25021-0185-11 ganciclovir 50 mg/mL Details
ganciclovir 50 mg/mL
ganciclovir is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sagent Pharmaceuticals. 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: 25021-0185-11Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ganciclovir Injection
Product Information
NDC | 25021-0185 |
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Product ID | 25021-185_696f706f-39d7-4647-a506-2ebf7b956cc1 |
Associated GPIs | 12200030102030 |
GCN Sequence Number | 078313 |
GCN Sequence Number Description | ganciclovir sodium VIAL 500MG/10ML INTRAVEN |
HIC3 | W5A |
HIC3 Description | ANTIVIRALS, GENERAL |
GCN | 44623 |
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, SOLUTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 50 |
Active Ingredient Units | mg/mL |
Substance Name | GANCICLOVIR SODIUM |
Labeler Name | Sagent Pharmaceuticals |
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 | ANDA207645 |
Listing Certified Through | 2024-12-31 |
Package
NDC 25021-0185-11 (25021018511)
NDC Package Code | 25021-185-11 |
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Billing NDC | 25021018511 |
Package | 1 VIAL in 1 CARTON (25021-185-11) / 10 mL in 1 VIAL |
Marketing Start Date | 2019-12-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |