FDA.reportPublic FDA data

Valganciclovir

Product NDC
31722-832
11-digit product format
317220832
Labeler code
31722
Product ID
31722-832_2b44d151-5b10-9250-e063-6294a90a53c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205166
Marketing category
ANDA
Marketing start
2016-03-18
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
31722-832-31Valganciclovir10 in 1 BLISTER PACKTABLET, FILM COATED105
31722-832-32Valganciclovir10 in 1 CARTONTABLET, FILM COATED105
31722-832-60Valganciclovir60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-832-60EA - Each31722-832859134d8-3384-4073-b0fc-edef781fe2de12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-832VALGANCICLOVIR (VALGANCICLOVIR) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 3 package rows20250112_383e8810-b877-4a4f-abdf-c8c4c8e394f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313566valGANciclovir HCl 450 MG Oral TabletPSN6a6533fd-0579-4059-ba87-aa399829a8b06
313566valGANciclovir HCl 450 MG Oral TabletPSN85177859-e0f5-6d83-17f3-29cae1db96c36
313566valganciclovir 450 MG Oral TabletSCD6a6533fd-0579-4059-ba87-aa399829a8b06
313566valganciclovir 450 MG Oral TabletSCD85177859-e0f5-6d83-17f3-29cae1db96c36
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY6a6533fd-0579-4059-ba87-aa399829a8b06
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY85177859-e0f5-6d83-17f3-29cae1db96c36
313566valGANciclovir HCl 450 MG Oral TabletPSN383e8810-b877-4a4f-abdf-c8c4c8e394f85
313566valganciclovir 450 MG Oral TabletSCD383e8810-b877-4a4f-abdf-c8c4c8e394f85
313566valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral TabletSY383e8810-b877-4a4f-abdf-c8c4c8e394f85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-832-313172208323110 TABLET, FILM COATED in 1 BLISTER PACK (31722-832-31) 2016-03-180000-00-00NoNoCurrent
31722-832-323172208323210 TABLET, FILM COATED in 1 CARTON (31722-832-32) 2016-03-180000-00-00NoNoCurrent
31722-832-603172208326060 TABLET, FILM COATED in 1 BOTTLE (31722-832-60) 2016-03-180000-00-00NoNoCurrent