FDA.reportPublic FDA data

Valganciclovir

Product NDC
64380-161
11-digit product format
643800161
Labeler code
64380
Product ID
64380-161_058fa4c8-4170-4506-a930-dcacb28d9eff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA200790
Marketing category
ANDA
Marketing start
2025-06-16
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
64380-161-01Valganciclovir60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-161-01EA - Each64380-161f9836293-3cb6-481a-a04f-2faf46e0b5f012025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313566valGANciclovir HCl 450 MG Oral TabletPSN89a934f0-85a3-44c1-82e5-d09d1738e08d2
313566valganciclovir 450 MG Oral TabletSCD89a934f0-85a3-44c1-82e5-d09d1738e08d2
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY89a934f0-85a3-44c1-82e5-d09d1738e08d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64380-161-016438001610160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-161-01) 2025-06-16NoNoCurrent