FDA.reportPublic FDA data

Valganciclovir

Product NDC
60687-765
11-digit product format
606870765
Labeler code
60687
Product ID
60687-765_038956dc-dd87-2583-e063-6294a90aa282
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir Hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA211475
Marketing category
ANDA
Marketing start
2023-08-20
Substance
VALGANCICLOVIR HYDROCHLORIDE
Active strength
50 mg/mL
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 HYDROCHLORIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4P3T9QF9NZ
Rxcui863559

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ca79b117-2321-7bf9-3481-6c7a7e8ddd86Product name920221206
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
9f9c8b60-edb9-4f29-9472-12fa266e8eadProduct name520190912
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
db601a58-ade5-4a08-a9d0-73d4222e8e5aProduct name120170505
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
af7ea8c4-c902-5a51-fdbc-62597b8c28f9Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-765-13Valganciclovir100 mL in 1 BOTTLE, GLASSPOWDER, FOR SOLUTION1001
60687-765-13Valganciclovir1 in 1 CARTONPOWDER, FOR SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-765-13ML - Milliliter60687-765e7bc7c34-c2ff-43b1-93a8-7add2140648512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-765VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20230823_0e30509f-add6-43c8-9e1d-e10c55a207e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863559valGANciclovir 50 MG in 1 mL Oral SolutionPSN0e30509f-add6-43c8-9e1d-e10c55a207e61
863559valganciclovir 50 MG/ML Oral SolutionSCD0e30509f-add6-43c8-9e1d-e10c55a207e61
863559valganciclovir (as valganciclovir hydrochloride) 50 MG/ML Oral SolutionSY0e30509f-add6-43c8-9e1d-e10c55a207e61
863559valganciclovir 50 MG per 1 ML Oral SolutionSY0e30509f-add6-43c8-9e1d-e10c55a207e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60687-765-13606870765131 BOTTLE, GLASS in 1 CARTON (60687-765-13) / 100 mL in 1 BOTTLE, GLASS2023-08-20NoNoCurrent