FDA.reportPublic FDA data

Valganciclovir

Product NDC
0904-6796
11-digit product format
009046796
Labeler code
0904
Product ID
0904-6796_d77110cf-ef90-4565-a751-8ebedc10c2aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA205166
Marketing category
ANDA
Marketing start
2016-03-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valganciclovir
Listing expiration
2027-12-31

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
0904-6796-04Valganciclovir30 in 1 CARTONTABLET, FILM COATED306
0904-6796-04Valganciclovir1 in 1 BLISTER PACKTABLET, FILM COATED16
0904-6796-10Valganciclovir20 in 1 CARTONTABLET, FILM COATED206
0904-6796-10Valganciclovir1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6796-04EA - Each0904-6796dbff1e7d-b963-4d19-ac59-3f44ef16284e12018-10-11
0904-6796-10EA - Each0904-679684e16f4d-b5a2-4a1c-a674-f6738194558d12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6796VALGANCICLOVIR TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20250313_6a6533fd-0579-4059-ba87-aa399829a8b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313566valGANciclovir HCl 450 MG Oral TabletPSN6a6533fd-0579-4059-ba87-aa399829a8b06
313566valganciclovir 450 MG Oral TabletSCD6a6533fd-0579-4059-ba87-aa399829a8b06
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY6a6533fd-0579-4059-ba87-aa399829a8b06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6796-040090467960430 BLISTER PACK in 1 CARTON (0904-6796-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2016-03-180000-00-00NoNoCurrent
0904-6796-100090467961020 BLISTER PACK in 1 CARTON (0904-6796-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK20 blister pack2016-03-180000-00-00NoNoCurrent