FDA.reportPublic FDA data

VALACYCLOVIR

Product NDC
61919-515
11-digit product format
619190515
Labeler code
61919
Product ID
61919-515_874aa629-1333-0c30-e053-2a95a90ac888
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALACYCLOVIR
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA077135
Marketing category
ANDA
Marketing start
2019-04-24
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
61919-515-202025-01-30C16284748780-12cef2736-671e-d83d-e063-dadaa90ab31fVALACYCLOVIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-515-20VALACYCLOVIR20 in 1 BOTTLETABLET201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-515-20EA - Each61919-515fdb26cc3-7fd8-4181-b7f6-2f1b4ddd3bc912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-515VALACYCLOVIR TABLET [DIRECTRX]1Legacy NDC, 1 package rows20190425_874aa629-1332-0c30-e053-2a95a90ac888.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN874aa629-1332-0c30-e053-2a95a90ac8881
313565valacyclovir 500 MG Oral TabletSCD874aa629-1332-0c30-e053-2a95a90ac8881
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY874aa629-1332-0c30-e053-2a95a90ac8881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-515-206191905152020 TABLET in 1 BOTTLE (61919-515-20) 20 tablet2019-04-240000-00-00NoNoCurrent