Home NDC 0004-0038 Valcyte
Product NDC 0004-0038
11-digit product format 000040038
Labeler code 0004
Product ID 0004-0038_80c62d56-ae54-45a5-8121-16ef65a9bc48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valganciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Genentech, Inc.
Application NDA021304
Marketing category NDA
Marketing start 2001-03-29
Marketing end 0000-00-00
Substance VALGANCICLOVIR HYDROCHLORIDE
Active strength 450 mg/1
Pharmacologic classes Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded valganciclovir hydrochloride ACTIVE INGREDIENT 4P3T9QF9NZ VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 ganciclovir ACTIVE MOIETY P9G3CKZ4P5 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 ACACIA INACTIVE INGREDIENT 5C5403N26O VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 crospovidone INACTIVE INGREDIENT 68401960MK VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 fumaric acid INACTIVE INGREDIENT 88XHZ13131 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 mannitol INACTIVE INGREDIENT 3OWL53L36A VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 povidone K29/32 INACTIVE INGREDIENT 390RMW2PEQ VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 povidone k30 INACTIVE INGREDIENT U725QWY32X VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0004-0038 VALCYTE (VALGANCICLOVIR) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [GENENTECH, INC.] 23 Legacy NDC 20241120_dc548ff9-e8ea-4d6e-b9b4-e31f53ac4078.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0004-0038-22 00004003822 1 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2001-03-29 0000-00-00 No No Current