FDA.reportPublic FDA data

VALGANCICLOVIR HYDROCHLORIDE

Product NDC
65862-753
11-digit product format
658620753
Labeler code
65862
Product ID
65862-753_3d5cd566-06ab-4e83-aba8-f692ff8a23dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALGANCICLOVIR HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204750
Marketing category
ANDA
Marketing start
2016-03-31
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
65862-753-01VALGANCICLOVIR HYDROCHLORIDE100 in 1 BOTTLETABLET10012
65862-753-05VALGANCICLOVIR HYDROCHLORIDE500 in 1 BOTTLETABLET50012
65862-753-18VALGANCICLOVIR HYDROCHLORIDE180 in 1 BOTTLETABLET18012
65862-753-60VALGANCICLOVIR HYDROCHLORIDE60 in 1 BOTTLETABLET6012
65862-753-99VALGANCICLOVIR HYDROCHLORIDE1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-753-60EA - Each65862-75326090d4c-c2f0-49c3-a1fa-62becaa2720012016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-753VALGANCICLOVIR HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 5 package rows20240529_8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313566valGANciclovir HCl 450 MG Oral TabletPSN8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad8312
313566valganciclovir 450 MG Oral TabletSCD8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad8312
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY8d2ffc05-2fbc-41f8-8656-fbc0bfa7ad8312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-753-0165862075301100 TABLET in 1 BOTTLE (65862-753-01) 100 tablet2016-03-310000-00-00NoNoCurrent
65862-753-0565862075305500 TABLET in 1 BOTTLE (65862-753-05) 500 tablet2016-03-310000-00-00NoNoCurrent
65862-753-1865862075318180 TABLET in 1 BOTTLE (65862-753-18) 180 tablet2016-03-310000-00-00NoNoCurrent
65862-753-606586207536060 TABLET in 1 BOTTLE (65862-753-60) 60 tablet2016-03-310000-00-00NoNoCurrent
65862-753-99658620753991000 TABLET in 1 BOTTLE (65862-753-99) 1000 tablet2016-03-310000-00-00NoNoCurrent