FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
71335-1341
11-digit product format
713351341
Labeler code
71335
Product ID
71335-1341_97d0395b-b5bd-45d9-bd2b-a1791a787a5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078518
Marketing category
ANDA
Marketing start
2010-05-24
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC

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
71335-1341-0Valacyclovir Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
71335-1341-1Valacyclovir Hydrochloride15 in 1 BOTTLETABLET, FILM COATED155
71335-1341-2Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED105
71335-1341-3Valacyclovir Hydrochloride4 in 1 BOTTLETABLET, FILM COATED45
71335-1341-4Valacyclovir Hydrochloride7 in 1 BOTTLETABLET, FILM COATED75
71335-1341-5Valacyclovir Hydrochloride20 in 1 BOTTLETABLET, FILM COATED205
71335-1341-6Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
71335-1341-7Valacyclovir Hydrochloride8 in 1 BOTTLETABLET, FILM COATED85
71335-1341-8Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905
71335-1341-9Valacyclovir Hydrochloride14 in 1 BOTTLETABLET, FILM COATED145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1341VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20230331_c28c069f-3b51-4474-aa38-1aed6b7b8678.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNc28c069f-3b51-4474-aa38-1aed6b7b86785
313565valacyclovir 500 MG Oral TabletSCDc28c069f-3b51-4474-aa38-1aed6b7b86785
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYc28c069f-3b51-4474-aa38-1aed6b7b86785

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1341-07133513410060 TABLET, FILM COATED in 1 BOTTLE (71335-1341-0) 2019-11-080000-00-00NoNoCurrent
71335-1341-17133513410115 TABLET, FILM COATED in 1 BOTTLE (71335-1341-1) 2021-04-230000-00-00NoNoCurrent
71335-1341-27133513410210 TABLET, FILM COATED in 1 BOTTLE (71335-1341-2) 2019-09-130000-00-00NoNoCurrent
71335-1341-3713351341034 TABLET, FILM COATED in 1 BOTTLE (71335-1341-3) 2021-12-280000-00-00NoNoCurrent
71335-1341-4713351341047 TABLET, FILM COATED in 1 BOTTLE (71335-1341-4) 2020-09-040000-00-00NoNoCurrent
71335-1341-57133513410520 TABLET, FILM COATED in 1 BOTTLE (71335-1341-5) 2020-05-220000-00-00NoNoCurrent
71335-1341-67133513410630 TABLET, FILM COATED in 1 BOTTLE (71335-1341-6) 2019-09-120000-00-00NoNoCurrent
71335-1341-7713351341078 TABLET, FILM COATED in 1 BOTTLE (71335-1341-7) 2020-01-160000-00-00NoNoCurrent
71335-1341-87133513410890 TABLET, FILM COATED in 1 BOTTLE (71335-1341-8) 2021-12-280000-00-00NoNoCurrent
71335-1341-97133513410914 TABLET, FILM COATED in 1 BOTTLE (71335-1341-9) 2020-02-040000-00-00NoNoCurrent