FDA.reportPublic FDA data

VALGANCICLOVIR HYDROCHLORIDE

Product NDC
72603-750
11-digit product format
726030750
Labeler code
72603
Product ID
72603-750_1cc09039-dcd6-4721-abd4-411535ccf442
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALGANCICLOVIR HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA204750
Marketing category
ANDA
Marketing start
2026-03-01
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 HYDROCHLORIDE
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
72603-750-01VALGANCICLOVIR HYDROCHLORIDE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-750-01EA - Each72603-7503be57725-b2b5-4ab7-84d1-2a1fa894b90e12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313566valGANciclovir HCl 450 MG Oral TabletPSN1cc09039-dcd6-4721-abd4-411535ccf4421
313566valganciclovir 450 MG Oral TabletSCD1cc09039-dcd6-4721-abd4-411535ccf4421
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY1cc09039-dcd6-4721-abd4-411535ccf4421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-750-017260307500160 TABLET in 1 BOTTLE (72603-750-01) 60 tablet2026-03-01NoNoCurrent