FDA.reportPublic FDA data

Valacyclovir

Product NDC
50436-0704
11-digit product format
504360704
Labeler code
50436
Product ID
50436-0704_261c2510-bf93-4c75-b35c-922a69c9d4c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
Marketing end
0000-00-00
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
2020-12-31
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
50436-0704-12021-01-29C16284748780-1ba0f9c33-1449-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
50436-0704-32021-01-29C16284748780-1ba0f9c33-1449-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
50436-0704-42021-01-29C16284748780-1ba0f9c33-1449-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
50436-0704-52021-01-29C16284748780-1ba0f9c33-1449-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
50436-0704-62021-01-29C16284748780-1ba0f9c33-1449-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0704-1Valacyclovir30 in 1 BOTTLETABLET, FILM COATED303
50436-0704-3Valacyclovir90 in 1 BOTTLETABLET, FILM COATED903
50436-0704-4Valacyclovir12 in 1 BOTTLETABLET, FILM COATED123
50436-0704-5Valacyclovir15 in 1 BOTTLETABLET, FILM COATED153
50436-0704-6Valacyclovir24 in 1 BOTTLETABLET, FILM COATED243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0704VALACYCLOVIR TABLET, FILM COATED [UNIT DOSE SERVICES]3Legacy NDC, 5 package rows20190821_a9d61c88-6050-4a3a-8d0a-242217b8882c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valACYclovir 500 MG Oral TabletPSNa9d61c88-6050-4a3a-8d0a-242217b8882c3
313564valacyclovir 1000 MG Oral TabletSCDa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valacyclovir 500 MG Oral TabletSCDa9d61c88-6050-4a3a-8d0a-242217b8882c3
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYa9d61c88-6050-4a3a-8d0a-242217b8882c3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYa9d61c88-6050-4a3a-8d0a-242217b8882c3
313564valacyclovir 1 GM Oral TabletSYa9d61c88-6050-4a3a-8d0a-242217b8882c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0704-15043607040130 in 1 BOTTLEHistorical
50436-0704-35043607040390 in 1 BOTTLEHistorical
50436-0704-45043607040412 in 1 BOTTLEHistorical
50436-0704-55043607040515 in 1 BOTTLEHistorical
50436-0704-65043607040624 in 1 BOTTLEHistorical