Valacyclovir

Product NDC
61919-066
11-digit product format
619190066
Labeler code
61919
Product ID
61919-066_364a2f8b-adfa-b8ce-e063-6394a90a8f9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct Rx
Application
ANDA201506
Marketing category
ANDA
Marketing start
2015-01-01
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [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
Valacyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313565

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-066-20Valacyclovir20 in 1 BOTTLETABLET, FILM COATED203
61919-066-60Valacyclovir60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-066-20EA - Each61919-0662f5b4457-5583-4bb1-afa3-58be2aa0181812025-07-08
61919-066-60EA - Each61919-0663fa9d1b7-038e-4235-942c-2add14cbbf3912016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Valacyclovir HydrochlorideACTIVE INGREDIENTG447S0T1VCDIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FDIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WODIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ADIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-066VALACYCLOVIR TABLET [DIRECT RX]2Current NDC, Legacy NDC, 2 package rows20160923_cbd7bb49-7a9c-4383-a158-bfc307db0130.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNcbd7bb49-7a9c-4383-a158-bfc307db01303
313565valacyclovir 500 MG Oral TabletSCDcbd7bb49-7a9c-4383-a158-bfc307db01303
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYcbd7bb49-7a9c-4383-a158-bfc307db01303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61919-066-206191900662020 TABLET, FILM COATED in 1 BOTTLE (61919-066-20) 2015-01-01NoNoHistorical
61919-066-606191900666060 TABLET, FILM COATED in 1 BOTTLE (61919-066-60) 2015-01-01NoNoHistorical