FDA.reportPublic FDA data

Valganciclovir

Product NDC
60429-846
11-digit product format
604290846
Labeler code
60429
Product ID
60429-846_1274f28f-fd5b-f5f1-e063-6394a90ac7d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA203511
Marketing category
ANDA
Marketing start
2014-11-04
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
60429-846-60Valganciclovir60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-846-60EA - Each60429-84604fb2b76-bd5a-4d3e-9529-0436f4873bc012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-846VALGANCICLOVIR TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]5Current NDC, Legacy NDC, 1 package rows20240229_79f39244-dd20-acb3-e053-2a91aa0a4aee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313566valGANciclovir HCl 450 MG Oral TabletPSN79f39244-dd20-acb3-e053-2a91aa0a4aee5
313566valganciclovir 450 MG Oral TabletSCD79f39244-dd20-acb3-e053-2a91aa0a4aee5
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY79f39244-dd20-acb3-e053-2a91aa0a4aee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-846-606042908466060 TABLET, FILM COATED in 1 BOTTLE (60429-846-60) 2018-11-020000-00-00NoNoCurrent