FDA.reportPublic FDA data

Valganciclovir

Product NDC
42291-973
11-digit product format
422910973
Labeler code
42291
Product ID
42291-973_48c2e236-ce58-2ce4-e063-6294a90af3ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA200790
Marketing category
ANDA
Marketing start
2023-12-21
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
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
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
42291-973-60Valganciclovir60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-973-60EA - Each42291-9732fb7969e-5dad-4c88-b2b4-973d4e1381ee12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-973VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [AVKARE]1Current NDC, 1 package rows20231222_0d0bbc91-27f6-29bc-e063-6394a90a0027.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
42291-973-604229109736060 TABLET, FILM COATED in 1 BOTTLE (42291-973-60) 2023-12-21NoNoCurrent