Valganciclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Valganciclovir Hydrochloride.
| Product ID | 50268-787_6e13496f-d9b4-eac7-e053-2991aa0aebed |
| NDC | 50268-787 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Valganciclovir |
| Generic Name | Valganciclovir |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-07-27 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA205166 |
| Labeler Name | AvPAK |
| Substance Name | VALGANCICLOVIR HYDROCHLORIDE |
| Active Ingredient Strength | 450 mg/1 |
| Pharm Classes | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2016-07-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA205166 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-07-27 |
| Marketing Category | ANDA |
| Application Number | ANDA205166 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-07-27 |
| Ingredient | Strength |
|---|---|
| VALGANCICLOVIR HYDROCHLORIDE | 450 mg/1 |
| SPL SET ID: | 85177859-e0f5-6d83-17f3-29cae1db96c3 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0603-6330 | Valganciclovir | Valganciclovir hydrochloride |
| 0904-6796 | Valganciclovir | Valganciclovir |
| 16714-765 | Valganciclovir | Valganciclovir |
| 27241-158 | Valganciclovir | Valganciclovir |
| 31722-832 | Valganciclovir | Valganciclovir |
| 31722-837 | VALGANCICLOVIR | VALGANCICLOVIR HYDROCHLORIDE |
| 42291-875 | Valganciclovir | Valganciclovir hydrochloride |
| 48433-124 | Valganciclovir | Valganciclovir |
| 50268-787 | Valganciclovir | Valganciclovir |
| 55111-762 | Valganciclovir | Valganciclovir |
| 59651-444 | Valganciclovir | Valganciclovir hydrochloride powder, |
| 60429-846 | Valganciclovir | Valganciclovir |
| 63629-2288 | Valganciclovir | Valganciclovir hydrochloride |
| 63739-076 | Valganciclovir | Valganciclovir |
| 64380-153 | Valganciclovir | Valganciclovir hydrochloride |
| 68084-965 | Valganciclovir | Valganciclovir |
| 69097-277 | Valganciclovir | Valganciclovir |
| 0004-0038 | Valcyte | valganciclovir |