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NDC 00004-0039-09 Valcyte 50 mg/mL Details
Valcyte 50 mg/mL
Valcyte is a ORAL POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Genentech, Inc.. The primary component is VALGANCICLOVIR HYDROCHLORIDE.
MedlinePlus Drug Summary
Valganciclovir is used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people who have acquired immunodeficiency syndrome (AIDS). Valganciclovir is also used to prevent cytomegalovirus (CMV) disease in people who have received a heart, kidney, or kidney-pancreas transplant and who have a chance of getting CMV disease. Valganciclovir is in a class of medications called antivirals. It works by preventing the spread of CMV disease or slowing the growth of CMV.
Related Packages: 00004-0039-09Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Valganciclovir
Product Information
| NDC | 00004-0039 |
|---|---|
| Product ID | 0004-0039_489edd7b-59eb-40d9-83d5-abc96aaac2cb |
| Associated GPIs | 12200066102120 |
| GCN Sequence Number | 064506 |
| GCN Sequence Number Description | valganciclovir HCl SOLN RECON 50 MG/ML ORAL |
| HIC3 | W5A |
| HIC3 Description | ANTIVIRALS, GENERAL |
| GCN | 14453 |
| HICL Sequence Number | 022033 |
| HICL Sequence Number Description | VALGANCICLOVIR HCL |
| Brand/Generic | Brand |
| Proprietary Name | Valcyte |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | valganciclovir hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | VALGANCICLOVIR HYDROCHLORIDE |
| Labeler Name | Genentech, Inc. |
| 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 | NDA |
| Application Number | NDA022257 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00004-0039-09 (00004003909)
| NDC Package Code | 0004-0039-09 |
|---|---|
| Billing NDC | 00004003909 |
| Package | 1 BOTTLE, GLASS in 1 CARTON (0004-0039-09) / 100 mL in 1 BOTTLE, GLASS |
| Marketing Start Date | 2009-08-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |