FDA.reportPublic FDA data

Valcyte

Product NDC
61269-485
11-digit product format
612690485
Labeler code
61269
Product ID
61269-485_c70cbfa5-6b69-4fd4-8ad0-e819c8795746
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valganciclovir hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
H2-Pharma, LLC
Application
NDA022257
Marketing category
NDA
Marketing start
2009-08-28
Substance
VALGANCICLOVIR HYDROCHLORIDE
Active strength
50 mg/mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valcyte
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4P3T9QF9NZ
Rxcui284587, 313566, 863559, 863562

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca79b117-2321-7bf9-3481-6c7a7e8ddd86Product name920221206
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9f9c8b60-edb9-4f29-9472-12fa266e8eadProduct name520190912
db601a58-ade5-4a08-a9d0-73d4222e8e5aProduct name120170505
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
af7ea8c4-c902-5a51-fdbc-62597b8c28f9Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-485-10Valcyte100 mL in 1 BOTTLE, GLASSPOWDER, FOR SOLUTION10024
61269-485-10Valcyte1 in 1 CARTONPOWDER, FOR SOLUTION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-485-10ML - Milliliter61269-48546a2e375-d3c7-4ce7-b758-f2c6f7d25d6512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-485VALCYTE (VALGANCICLOVIR) TABLET, FILM COATED VALCYTE (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [H2-PHARMA, LLC]23Current NDC, 2 package rows20250112_4c517a39-2ded-4c5a-8d56-276853414b31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284587Valcyte 450 MG Oral TabletPSN4c517a39-2ded-4c5a-8d56-276853414b3124
863562Valcyte 50 MG in 1 mL Oral SolutionPSN4c517a39-2ded-4c5a-8d56-276853414b3124
863559valGANciclovir 50 MG in 1 mL Oral SolutionPSN4c517a39-2ded-4c5a-8d56-276853414b3124
313566valGANciclovir HCl 450 MG Oral TabletPSN4c517a39-2ded-4c5a-8d56-276853414b3124
284587valganciclovir 450 MG Oral Tablet [Valcyte]SBD4c517a39-2ded-4c5a-8d56-276853414b3124
863562valganciclovir 50 MG/ML Oral Solution [Valcyte]SBD4c517a39-2ded-4c5a-8d56-276853414b3124
313566valganciclovir 450 MG Oral TabletSCD4c517a39-2ded-4c5a-8d56-276853414b3124
863559valganciclovir 50 MG/ML Oral SolutionSCD4c517a39-2ded-4c5a-8d56-276853414b3124
863562Valcyte (as valganciclovir hydrochloride) 50 MG/ML Oral SolutionSY4c517a39-2ded-4c5a-8d56-276853414b3124
284587Valcyte 450 MG (valganciclovir hydrochloride 496.3 MG) Oral TabletSY4c517a39-2ded-4c5a-8d56-276853414b3124
284587Valcyte 450 MG Oral TabletSY4c517a39-2ded-4c5a-8d56-276853414b3124
863562Valcyte 50 MG per 1 ML Oral SolutionSY4c517a39-2ded-4c5a-8d56-276853414b3124
863562Valcyte 50 MG/ML Oral SolutionSY4c517a39-2ded-4c5a-8d56-276853414b3124
863559valganciclovir (as valganciclovir hydrochloride) 50 MG/ML Oral SolutionSY4c517a39-2ded-4c5a-8d56-276853414b3124
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY4c517a39-2ded-4c5a-8d56-276853414b3124
863559valganciclovir 50 MG per 1 ML Oral SolutionSY4c517a39-2ded-4c5a-8d56-276853414b3124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61269-485-10612690485101 BOTTLE, GLASS in 1 CARTON (61269-485-10) / 100 mL in 1 BOTTLE, GLASS2009-08-28NoNoCurrent