NDC 0004-0038

Valcyte

Valganciclovir

Valcyte is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Valganciclovir Hydrochloride.

• Product ID: 0004-0038_11d60ca4-c31d-4fa4-8606-13541e8dbee2
• NDC: 0004-0038
• Product Type: Human Prescription Drug
• Proprietary Name: Valcyte
• Generic Name: Valganciclovir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2001-03-29
• Marketing Category: NDA / NDA
• Application Number: NDA021304
• Labeler Name: Genentech, Inc.
• 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: 2021-12-31

Packaging

NDC 0004-0038-22

1 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2001-03-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0004-0038-86 [00004003886]

Valcyte TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021304
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-03-09
• Marketing End Date: 2017-11-30

NDC 0004-0038-22 [00004003822]

Valcyte TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021304
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-03-29

Drug Details

Active Ingredients

Ingredient	Strength
VALGANCICLOVIR HYDROCHLORIDE	450 mg/1

OpenFDA Data

• SPL SET ID: dc548ff9-e8ea-4d6e-b9b4-e31f53ac4078
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • 4P3T9QF9NZ
• RxNorm Concept Unique ID - RxCUI:
  • 863562
  • 863559
  • 313566
  • 284587

Pharmacological Class

• Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• DNA Polymerase Inhibitors [MoA]
• Nucleoside Analog [EXT]
• Nucleoside Analog Antiviral [EPC]

NDC Crossover Matching brand name "Valcyte" or generic name "Valganciclovir"

NDC	Brand Name	Generic Name
0004-0038	Valcyte	valganciclovir
0004-0039	Valcyte	valganciclovir hydrochloride
0904-6796	Valganciclovir	Valganciclovir
16714-765	Valganciclovir	Valganciclovir
27241-158	Valganciclovir	Valganciclovir
31722-832	Valganciclovir	Valganciclovir
48433-124	Valganciclovir	Valganciclovir
50268-787	Valganciclovir	Valganciclovir
55111-762	Valganciclovir	Valganciclovir
60429-846	Valganciclovir	Valganciclovir
63739-076	Valganciclovir	Valganciclovir
68084-965	Valganciclovir	Valganciclovir
69097-277	Valganciclovir	Valganciclovir