FDA.reportPublic FDA data

Valganciclovir

Product NDC
71921-210
11-digit product format
719210210
Labeler code
71921
Product ID
71921-210_cc6c4939-7908-439c-b1b8-6b52e826c7a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA216317
Marketing category
ANDA
Marketing start
2023-07-01
Substance
VALGANCICLOVIR
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
VALGANCICLOVIR50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGCU97FKN3R
Rxcui863559

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca79b117-2321-7bf9-3481-6c7a7e8ddd86Product name920221206
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
71921-210-12Valganciclovir100 mL in 1 BOTTLEPOWDER, FOR SOLUTION1001
71921-210-12Valganciclovir1 in 1 CARTONPOWDER, FOR SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-210-12ML - Milliliter71921-21034a396e7-3ed2-4a67-99b8-48387c58820012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-210VALGANCICLOVIR POWDER, FOR SOLUTION [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]1Current NDC, 2 package rows20230714_cc6c4939-7908-439c-b1b8-6b52e826c7a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863559valGANciclovir 50 MG in 1 mL Oral SolutionPSNcc6c4939-7908-439c-b1b8-6b52e826c7a51
863559valganciclovir 50 MG/ML Oral SolutionSCDcc6c4939-7908-439c-b1b8-6b52e826c7a51
863559valganciclovir (as valganciclovir hydrochloride) 50 MG/ML Oral SolutionSYcc6c4939-7908-439c-b1b8-6b52e826c7a51
863559valganciclovir 50 MG per 1 ML Oral SolutionSYcc6c4939-7908-439c-b1b8-6b52e826c7a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-210-12719210210121 BOTTLE in 1 CARTON (71921-210-12) / 100 mL in 1 BOTTLE1 bottle2023-07-01NoNoHistorical