FDA.reportPublic FDA data

Valacyclovir

Product NDC
68071-3332
11-digit product format
680713332
Labeler code
68071
Product ID
68071-3332_b2c34132-33e7-9638-e053-2995a90a0194
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
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
2022-12-31
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
68071-3332-22025-01-30C16284748780-1f386c649-991f-0266-e053-dadaa90a7c1aHIGHLIGHTS 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
68071-3332-42025-01-30C16284748780-1f386c649-991f-0266-e053-dadaa90a7c1aHIGHLIGHTS 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
68071-3332-22023-01-31C16284748780-1f386c649-991f-0266-e053-dadaa90a7c1aHIGHLIGHTS 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
68071-3332-42023-01-31C16284748780-1f386c649-991f-0266-e053-dadaa90a7c1aHIGHLIGHTS 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
68071-3332-2Valacyclovir2 in 1 BOTTLETABLET, FILM COATED24
68071-3332-4Valacyclovir4 in 1 BOTTLETABLET, FILM COATED44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3332VALACYCLOVIR TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 2 package rows20230131_544eb47f-1622-1773-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN544eb47f-1622-1773-e054-00144ff8d46c4
313564valacyclovir 1000 MG Oral TabletSCD544eb47f-1622-1773-e054-00144ff8d46c4
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY544eb47f-1622-1773-e054-00144ff8d46c4
313564valacyclovir 1 GM Oral TabletSY544eb47f-1622-1773-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3332-2680713332022 TABLET, FILM COATED in 1 BOTTLE (68071-3332-2) 2017-07-140000-00-00NoNoCurrent
68071-3332-4680713332044 TABLET, FILM COATED in 1 BOTTLE (68071-3332-4) 2017-07-140000-00-00NoNoCurrent