FDA.reportPublic FDA data

Valacyclovir hydrochloride

Product NDC
70934-301
11-digit product format
709340301
Labeler code
70934
Product ID
70934-301_b7b407d0-c114-6d67-e053-2a95a90ac38f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA077135
Marketing category
ANDA
Marketing start
2019-03-01
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
2021-12-31
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
70934-301-142022-01-28C16284748780-1d6a99b39-e8d0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-301-14Valacyclovir hydrochloride14 in 1 BOTTLE, PLASTICTABLET142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-301VALACYCLOVIR HYDROCHLORIDE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 1 package rows20201231_8b9c314b-5c34-3bd7-e053-2a95a90a573f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN8b9c314b-5c34-3bd7-e053-2a95a90a573f2
313565valacyclovir 500 MG Oral TabletSCD8b9c314b-5c34-3bd7-e053-2a95a90a573f2
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY8b9c314b-5c34-3bd7-e053-2a95a90a573f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-301-147093403011414 TABLET in 1 BOTTLE, PLASTIC (70934-301-14) 14 tablet2019-03-010000-00-00NoNoCurrent