FDA.reportPublic FDA data

Valacyclovir hydrochloride

Product NDC
68788-6896
11-digit product format
687886896
Labeler code
68788
Product ID
68788-6896_7c60d1d2-a924-4118-9d74-b5c5d0c4d0a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077135
Marketing category
ANDA
Marketing start
2017-02-13
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

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
68788-6896-1Valacyclovir hydrochloride10 in 1 BOTTLETABLET108
68788-6896-2Valacyclovir hydrochloride20 in 1 BOTTLETABLET208
68788-6896-3Valacyclovir hydrochloride30 in 1 BOTTLETABLET308
68788-6896-4Valacyclovir hydrochloride4 in 1 BOTTLETABLET48
68788-6896-6Valacyclovir hydrochloride6 in 1 BOTTLETABLET68
68788-6896-7Valacyclovir hydrochloride21 in 1 BOTTLETABLET218

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6896VALACYCLOVIR HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 6 package rows20240824_c153155b-69dc-41b7-91d2-0949ec496174.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNc153155b-69dc-41b7-91d2-0949ec4961748
313565valacyclovir 500 MG Oral TabletSCDc153155b-69dc-41b7-91d2-0949ec4961748
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYc153155b-69dc-41b7-91d2-0949ec4961748

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-6896-16878868960110 TABLET in 1 BOTTLE (68788-6896-1) 10 tablet2017-02-130000-00-00NoNoCurrent
68788-6896-26878868960220 TABLET in 1 BOTTLE (68788-6896-2) 20 tablet2017-02-130000-00-00NoNoCurrent
68788-6896-36878868960330 TABLET in 1 BOTTLE (68788-6896-3) 30 tablet2017-02-130000-00-00NoNoCurrent
68788-6896-4687886896044 TABLET in 1 BOTTLE (68788-6896-4) 4 tablet2017-02-130000-00-00NoNoCurrent
68788-6896-6687886896066 TABLET in 1 BOTTLE (68788-6896-6) 6 tablet2017-02-130000-00-00NoNoCurrent
68788-6896-76878868960721 TABLET in 1 BOTTLE (68788-6896-7) 21 tablet2017-02-130000-00-00NoNoCurrent