FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
53002-0061
11-digit product format
530020061
Labeler code
53002
Product ID
53002-0061_2cb39722-4943-4b29-b82a-15f75c070100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090682
Marketing category
ANDA
Marketing start
2010-05-24
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
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
53002-0061-02025-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-12025-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-22025-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-32025-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-42025-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-52025-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-62025-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-02023-06-07C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-12023-06-07C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-22023-06-07C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-32023-06-07C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-42023-06-07C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-52023-06-07C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-62023-06-07C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-02023-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-12023-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-22023-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-32023-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-42023-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-52023-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-62023-01-30C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-02020-12-15C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-12020-12-15C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-22020-12-15C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-32020-12-15C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-42020-12-15C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-52020-12-15C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-62020-12-15C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-02020-01-31C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-12020-01-31C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-22020-01-31C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-32020-01-31C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-42020-01-31C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-52020-01-31C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
53002-0061-62020-01-31C16284748780-19d75b9d0-913f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0061-0Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
53002-0061-1Valacyclovir Hydrochloride2 in 1 BOTTLETABLET, FILM COATED27
53002-0061-2Valacyclovir Hydrochloride4 in 1 BOTTLETABLET, FILM COATED47
53002-0061-3Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED107
53002-0061-4Valacyclovir Hydrochloride14 in 1 BOTTLETABLET, FILM COATED147
53002-0061-5Valacyclovir Hydrochloride20 in 1 BOTTLETABLET, FILM COATED207
53002-0061-6Valacyclovir Hydrochloride21 in 1 BOTTLETABLET, FILM COATED217

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0061VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]7Legacy NDC, 7 package rows20230609_1ef0f51a-f730-435c-bc0d-2175fee91a9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313565valACYclovir 500 MG Oral TabletPSN1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir 1000 MG Oral TabletSCD1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313565valacyclovir 500 MG Oral TabletSCD1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir 1 GM Oral TabletSY1ef0f51a-f730-435c-bc0d-2175fee91a9e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-0061-05300200610030 TABLET, FILM COATED in 1 BOTTLE (53002-0061-0) 2018-10-010000-00-00NoNoCurrent
53002-0061-1530020061012 TABLET, FILM COATED in 1 BOTTLE (53002-0061-1) 2018-10-010000-00-00NoNoCurrent
53002-0061-2530020061024 TABLET, FILM COATED in 1 BOTTLE (53002-0061-2) 2018-10-010000-00-00NoNoCurrent
53002-0061-35300200610310 TABLET, FILM COATED in 1 BOTTLE (53002-0061-3) 2018-10-010000-00-00NoNoCurrent
53002-0061-45300200610414 TABLET, FILM COATED in 1 BOTTLE (53002-0061-4) 2018-10-010000-00-00NoNoCurrent
53002-0061-55300200610520 TABLET, FILM COATED in 1 BOTTLE (53002-0061-5) 2018-10-010000-00-00NoNoCurrent
53002-0061-65300200610621 TABLET, FILM COATED in 1 BOTTLE (53002-0061-6) 2018-10-010000-00-00NoNoCurrent