FDA.reportPublic FDA data

VALACYCLOVIR HYDROCHLORIDE

Product NDC
76519-1147
11-digit product format
765191147
Labeler code
76519
Product ID
76519-1147_8f8b0fb5-cbec-da8f-e053-2a95a90ae241
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALACYCLOVIR HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077135
Marketing category
ANDA
Marketing start
2017-01-30
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
76519-1147-12022-01-28C16284748780-1d6a99b39-b928-a426-e053-dadaa90af4c21147 VALACYCLOVIR HCL 500MG
76519-1147-32022-01-28C16284748780-1d6a99b39-b928-a426-e053-dadaa90af4c21147 VALACYCLOVIR HCL 500MG
76519-1147-42022-01-28C16284748780-1d6a99b39-b928-a426-e053-dadaa90af4c21147 VALACYCLOVIR HCL 500MG
76519-1147-92022-01-28C16284748780-1d6a99b39-b928-a426-e053-dadaa90af4c21147 VALACYCLOVIR HCL 500MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1147-1VALACYCLOVIR HYDROCHLORIDE10 in 1 BOTTLETABLET101
76519-1147-3VALACYCLOVIR HYDROCHLORIDE30 in 1 BOTTLETABLET301
76519-1147-4VALACYCLOVIR HYDROCHLORIDE14 in 1 BOTTLETABLET141
76519-1147-9VALACYCLOVIR HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1147VALACYCLOVIR HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 4 package rows20190809_8f8b0fb5-cbeb-da8f-e053-2a95a90ae241.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN8f8b0fb5-cbeb-da8f-e053-2a95a90ae2411
313565valacyclovir 500 MG Oral TabletSCD8f8b0fb5-cbeb-da8f-e053-2a95a90ae2411
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY8f8b0fb5-cbeb-da8f-e053-2a95a90ae2411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76519-1147-17651911470110 TABLET in 1 BOTTLE (76519-1147-1) 10 tablet2017-01-300000-00-00NoNoCurrent
76519-1147-37651911470330 TABLET in 1 BOTTLE (76519-1147-3) 30 tablet2017-01-300000-00-00NoNoCurrent
76519-1147-47651911470414 TABLET in 1 BOTTLE (76519-1147-4) 14 tablet2017-01-300000-00-00NoNoCurrent
76519-1147-97651911470990 TABLET in 1 BOTTLE (76519-1147-9) 90 tablet2017-01-300000-00-00NoNoCurrent