FDA.reportPublic FDA data

Valganciclovir hydrochloride

Product NDC
27241-159
11-digit product format
272410159
Labeler code
27241
Product ID
27241-159_6f6211f4-3501-4957-92a1-bd68f2962203
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valganciclovir hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA212890
Marketing category
ANDA
Marketing start
2020-01-13
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
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 HYDROCHLORIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4P3T9QF9NZ
Rxcui863559

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca79b117-2321-7bf9-3481-6c7a7e8ddd86Product name920221206
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
9f9c8b60-edb9-4f29-9472-12fa266e8eadProduct name520190912
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
db601a58-ade5-4a08-a9d0-73d4222e8e5aProduct name120170505
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
27241-159-19Valganciclovir hydrochloride1 in 1 CARTONPOWDER, FOR SOLUTION19
27241-159-19Valganciclovir hydrochloride1 in 1 POUCHPOWDER, FOR SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-159-19ML - Milliliter27241-159a91169c7-5904-4837-bb7f-5d2d1b41e34c12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-159VALGANCICLOVIR HYDROCHLORIDE POWDER, FOR SOLUTION [AJANTA PHARMA USA INC.]8Current NDC, Legacy NDC, 2 package rows20220111_178a014b-92c7-44a7-abb8-95d89a2feb8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863559valGANciclovir 50 MG in 1 mL Oral SolutionPSN178a014b-92c7-44a7-abb8-95d89a2feb8f9
863559valganciclovir 50 MG/ML Oral SolutionSCD178a014b-92c7-44a7-abb8-95d89a2feb8f9
863559valganciclovir (as valganciclovir hydrochloride) 50 MG/ML Oral SolutionSY178a014b-92c7-44a7-abb8-95d89a2feb8f9
863559valganciclovir 50 MG per 1 ML Oral SolutionSY178a014b-92c7-44a7-abb8-95d89a2feb8f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-159-19272410159191 POUCH in 1 CARTON (27241-159-19) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE1 pouch2020-01-130000-00-00NoNoCurrent