FDA.reportPublic FDA data

VALACYCLOVIR HYDROCHLORIDE

Product NDC
55648-153
11-digit product format
556480153
Labeler code
55648
Product ID
55648-153_88df95c2-5088-4980-9d78-2d1760033ba7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALACYCLOVIR HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA090216
Marketing category
ANDA
Marketing start
2010-05-24
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-153-012020-01-31C16284748780-19d75b9d0-0433-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995
55648-153-022020-01-31C16284748780-19d75b9d0-0433-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995
55648-153-032020-01-31C16284748780-19d75b9d0-0433-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995
55648-153-042020-01-31C16284748780-19d75b9d0-0433-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995
55648-153-052020-01-31C16284748780-19d75b9d0-0433-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995
55648-153-062020-01-31C16284748780-19d75b9d0-0433-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-153-01VALACYCLOVIR HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED212
55648-153-02VALACYCLOVIR HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
55648-153-03VALACYCLOVIR HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902
55648-153-04VALACYCLOVIR HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5002
55648-153-05VALACYCLOVIR HYDROCHLORIDE10 in 1 CARTONTABLET, FILM COATED102
55648-153-05VALACYCLOVIR HYDROCHLORIDE10 in 1 BLISTER PACKTABLET, FILM COATED102
55648-153-06VALACYCLOVIR HYDROCHLORIDE250 in 1 BOTTLETABLET, FILM COATED2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-153VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 7 package rows20130403_a9e1d18e-ad45-4183-bd98-53c7e0b36556.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNa9e1d18e-ad45-4183-bd98-53c7e0b365562
313565valACYclovir 500 MG Oral TabletPSNa9e1d18e-ad45-4183-bd98-53c7e0b365562
313564valacyclovir 1000 MG Oral TabletSCDa9e1d18e-ad45-4183-bd98-53c7e0b365562
313565valacyclovir 500 MG Oral TabletSCDa9e1d18e-ad45-4183-bd98-53c7e0b365562
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYa9e1d18e-ad45-4183-bd98-53c7e0b365562
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYa9e1d18e-ad45-4183-bd98-53c7e0b365562
313564valacyclovir 1 GM Oral TabletSYa9e1d18e-ad45-4183-bd98-53c7e0b365562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-153-015564801530121 in 1 BOTTLEHistorical
55648-153-025564801530230 in 1 BOTTLEHistorical
55648-153-035564801530390 in 1 BOTTLEHistorical
55648-153-0455648015304500 in 1 BOTTLEHistorical
55648-153-055564801530510 in 1 CARTONHistorical
55648-153-0655648015306250 in 1 BOTTLEHistorical