FDA.reportPublic FDA data

VALACYCLOVIR

Product NDC
72189-051
11-digit product format
721890051
Labeler code
72189
Product ID
72189-051_dc9cd06b-42af-02cf-e053-2995a90ab2fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALACYCLOVIR
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA203047
Marketing category
ANDA
Marketing start
2020-06-17
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
2023-12-31
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
72189-051-212025-01-30C16284748780-12cef2736-9c48-d83d-e063-dadaa90ab31fVALACYCLOVIR HYDROCHLORIDE
72189-051-302025-01-30C16284748780-12cef2736-9c48-d83d-e063-dadaa90ab31fVALACYCLOVIR HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-051-21VALACYCLOVIR21 in 1 BOTTLETABLET, FILM COATED218
72189-051-30VALACYCLOVIR30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-051ACYCLOVIR TABLET VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED VALACYCLOVIR TABLET, FILM COATED [DIRECT RX]8Legacy NDC, 2 package rows20230630_97a10bb6-52c0-495d-e053-2995a90a60a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN97a10bb6-52c0-495d-e053-2995a90a60a48
313564valACYclovir 1 GM Oral TabletPSN97a10bb6-52c0-495d-e053-2995a90a60a48
197313acyclovir 800 MG Oral TabletSCD97a10bb6-52c0-495d-e053-2995a90a60a48
313564valacyclovir 1000 MG Oral TabletSCD97a10bb6-52c0-495d-e053-2995a90a60a48
197313acycycloguanosine 800 MG Oral TabletSY97a10bb6-52c0-495d-e053-2995a90a60a48
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY97a10bb6-52c0-495d-e053-2995a90a60a48
313564valacyclovir 1 GM Oral TabletSY97a10bb6-52c0-495d-e053-2995a90a60a48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-051-217218900512121 TABLET, FILM COATED in 1 BOTTLE (72189-051-21) 2020-06-170000-00-00NoNoCurrent
72189-051-307218900513030 TABLET, FILM COATED in 1 BOTTLE (72189-051-30) 2020-06-170000-00-00NoNoCurrent