FDA.reportPublic FDA data

Valacyclovir

Product NDC
71335-2566
11-digit product format
713352566
Labeler code
71335
Product ID
71335-2566_20567a71-8bfc-47d2-922b-4ff642aba801
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209553
Marketing category
ANDA
Marketing start
2023-02-14
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
71335-2566-0Valacyclovir60 in 1 BOTTLETABLET601
71335-2566-1Valacyclovir15 in 1 BOTTLETABLET151
71335-2566-2Valacyclovir10 in 1 BOTTLETABLET101
71335-2566-3Valacyclovir4 in 1 BOTTLETABLET41
71335-2566-4Valacyclovir7 in 1 BOTTLETABLET71
71335-2566-5Valacyclovir20 in 1 BOTTLETABLET201
71335-2566-6Valacyclovir30 in 1 BOTTLETABLET301
71335-2566-7Valacyclovir8 in 1 BOTTLETABLET81
71335-2566-8Valacyclovir90 in 1 BOTTLETABLET901
71335-2566-9Valacyclovir14 in 1 BOTTLETABLET141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2566VALACYCLOVIR TABLET [BRYANT RANCH PREPACK]1Current NDC, 10 package rows20250207_65d13d0e-cf7f-4422-81f1-3dfce4722718.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN65d13d0e-cf7f-4422-81f1-3dfce47227181
313565valacyclovir 500 MG Oral TabletSCD65d13d0e-cf7f-4422-81f1-3dfce47227181
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY65d13d0e-cf7f-4422-81f1-3dfce47227181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2566-07133525660060 TABLET in 1 BOTTLE (71335-2566-0) 60 tablet2025-02-05NoNoCurrent
71335-2566-17133525660115 TABLET in 1 BOTTLE (71335-2566-1) 15 tablet2025-02-05NoNoCurrent
71335-2566-27133525660210 TABLET in 1 BOTTLE (71335-2566-2) 10 tablet2025-02-05NoNoCurrent
71335-2566-3713352566034 TABLET in 1 BOTTLE (71335-2566-3) 4 tablet2025-02-05NoNoCurrent
71335-2566-4713352566047 TABLET in 1 BOTTLE (71335-2566-4) 7 tablet2025-02-05NoNoCurrent
71335-2566-57133525660520 TABLET in 1 BOTTLE (71335-2566-5) 20 tablet2025-02-05NoNoCurrent
71335-2566-67133525660630 TABLET in 1 BOTTLE (71335-2566-6) 30 tablet2025-02-05NoNoCurrent
71335-2566-7713352566078 TABLET in 1 BOTTLE (71335-2566-7) 8 tablet2025-02-05NoNoCurrent
71335-2566-87133525660890 TABLET in 1 BOTTLE (71335-2566-8) 90 tablet2025-02-05NoNoCurrent
71335-2566-97133525660914 TABLET in 1 BOTTLE (71335-2566-9) 14 tablet2025-02-05NoNoCurrent