FDA.reportPublic FDA data

Valganciclovir

Product NDC
50268-787
11-digit product format
502680787
Labeler code
50268
Product ID
50268-787_4745ad6c-8db3-18af-e063-6394a90a0814
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA205166
Marketing category
ANDA
Marketing start
2016-07-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALGANCICLOVIR HYDROCHLORIDE450 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4P3T9QF9NZ
Rxcui313566

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca79b117-2321-7bf9-3481-6c7a7e8ddd86Product name920221206
9f9c8b60-edb9-4f29-9472-12fa266e8eadProduct name520190912
db601a58-ade5-4a08-a9d0-73d4222e8e5aProduct name120170505
af7ea8c4-c902-5a51-fdbc-62597b8c28f9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-787-11Valganciclovir1 in 1 BLISTER PACKTABLET, FILM COATED16
50268-787-12Valganciclovir20 in 1 BOX, UNIT-DOSETABLET, FILM COATED206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-787-11EA - Each50268-7873f47a458-362c-4b37-8dd3-62105d390c7812016-09-02
50268-787-12EA - Each50268-78771aea85a-5af0-4fd4-ba9f-f5cf6bfe81e712016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-787VALGANCICLOVIR TABLET, FILM COATED [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_85177859-e0f5-6d83-17f3-29cae1db96c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313566valGANciclovir HCl 450 MG Oral TabletPSN85177859-e0f5-6d83-17f3-29cae1db96c36
313566valganciclovir 450 MG Oral TabletSCD85177859-e0f5-6d83-17f3-29cae1db96c36
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY85177859-e0f5-6d83-17f3-29cae1db96c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-787-11502680787111 in 1 BLISTER PACKHistorical
50268-787-125026807871220 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-787-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-787-11) 20 blister pack2016-07-270000-00-00NoNoCurrent