FDA.reportPublic FDA data

Valganciclovir

Product NDC
64380-153
11-digit product format
643800153
Labeler code
64380
Product ID
64380-153_7b815816-a0ba-42d0-ba80-02894fa91b4b
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
2022-09-12
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
64380-153-01Valganciclovir60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-153-01EA - Each64380-153d1737825-e5d0-41f4-949e-9cac26398fc212022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-153VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]3Current NDC, Legacy NDC, 1 package rows20240124_390691b2-3db0-4b9f-934f-120674726f14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313566valGANciclovir HCl 450 MG Oral TabletPSN390691b2-3db0-4b9f-934f-120674726f143
313566valganciclovir 450 MG Oral TabletSCD390691b2-3db0-4b9f-934f-120674726f143
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY390691b2-3db0-4b9f-934f-120674726f143
313566valGANciclovir HCl 450 MG Oral TabletPSN0d0bbc91-27f6-29bc-e063-6394a90a00272
313566valganciclovir 450 MG Oral TabletSCD0d0bbc91-27f6-29bc-e063-6394a90a00272
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY0d0bbc91-27f6-29bc-e063-6394a90a00272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-153-016438001530160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-153-01) 2022-09-120000-00-00NoNoCurrent