FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
71335-1862
11-digit product format
713351862
Labeler code
71335
Product ID
71335-1862_18d8f022-a73f-4704-85b0-d9cafc35e035
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090682
Marketing category
ANDA
Marketing start
2010-05-24
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1 g/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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313564

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
71335-1862-0Valacyclovir Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60103
71335-1862-1Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30103
71335-1862-2Valacyclovir Hydrochloride21 in 1 BOTTLETABLET, FILM COATED21103
71335-1862-3Valacyclovir Hydrochloride20 in 1 BOTTLETABLET, FILM COATED20103
71335-1862-4Valacyclovir Hydrochloride4 in 1 BOTTLETABLET, FILM COATED4103
71335-1862-5Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED10103
71335-1862-6Valacyclovir Hydrochloride6 in 1 BOTTLETABLET, FILM COATED6103
71335-1862-7Valacyclovir Hydrochloride15 in 1 BOTTLETABLET, FILM COATED15103
71335-1862-8Valacyclovir Hydrochloride8 in 1 BOTTLETABLET, FILM COATED8103
71335-1862-9Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1862VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240830_4619bcc6-0070-4f3b-9cf9-900f3e5f7b19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN4619bcc6-0070-4f3b-9cf9-900f3e5f7b19103
313564valacyclovir 1000 MG Oral TabletSCD4619bcc6-0070-4f3b-9cf9-900f3e5f7b19103
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY4619bcc6-0070-4f3b-9cf9-900f3e5f7b19103
313564valacyclovir 1 GM Oral TabletSY4619bcc6-0070-4f3b-9cf9-900f3e5f7b19103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1862-07133518620060 TABLET, FILM COATED in 1 BOTTLE (71335-1862-0) 2021-10-210000-00-00NoNoCurrent
71335-1862-17133518620130 TABLET, FILM COATED in 1 BOTTLE (71335-1862-1) 2021-10-210000-00-00NoNoCurrent
71335-1862-27133518620221 TABLET, FILM COATED in 1 BOTTLE (71335-1862-2) 2021-10-210000-00-00NoNoCurrent
71335-1862-37133518620320 TABLET, FILM COATED in 1 BOTTLE (71335-1862-3) 2021-10-210000-00-00NoNoCurrent
71335-1862-4713351862044 TABLET, FILM COATED in 1 BOTTLE (71335-1862-4) 2021-10-210000-00-00NoNoCurrent
71335-1862-57133518620510 TABLET, FILM COATED in 1 BOTTLE (71335-1862-5) 2021-10-210000-00-00NoNoCurrent
71335-1862-6713351862066 TABLET, FILM COATED in 1 BOTTLE (71335-1862-6) 2021-10-210000-00-00NoNoCurrent
71335-1862-77133518620715 TABLET, FILM COATED in 1 BOTTLE (71335-1862-7) 2021-10-210000-00-00NoNoCurrent
71335-1862-8713351862088 TABLET, FILM COATED in 1 BOTTLE (71335-1862-8) 2021-10-210000-00-00NoNoCurrent
71335-1862-97133518620990 TABLET, FILM COATED in 1 BOTTLE (71335-1862-9) 2021-10-210000-00-00NoNoCurrent