FDA.reportPublic FDA data

Valacyclovir hydrochloride

Product NDC
67296-1226
11-digit product format
672961226
Labeler code
67296
Product ID
67296-1226_b8d0796c-80c2-1386-e053-2a95a90a676f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077135
Marketing category
ANDA
Marketing start
2010-05-24
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1000 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
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
67296-1226-12024-07-15C16284748780-1f386c64a-31d9-0266-e053-dadaa90a7c1aValacyclovir 1gm
67296-1226-12023-01-30C16284748780-1f386c64a-31d9-0266-e053-dadaa90a7c1aValacyclovir 1gm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1226-1Valacyclovir hydrochloride21 in 1 BOTTLETABLET219

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1226VALACYCLOVIR HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]9Legacy NDC, 1 package rows20240716_9613129c-2c1e-dbfd-e053-2a95a90af0cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN9613129c-2c1e-dbfd-e053-2a95a90af0cb9
313564valacyclovir 1000 MG Oral TabletSCD9613129c-2c1e-dbfd-e053-2a95a90af0cb9
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY9613129c-2c1e-dbfd-e053-2a95a90af0cb9
313564valacyclovir 1 GM Oral TabletSY9613129c-2c1e-dbfd-e053-2a95a90af0cb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1226-16729612260121 TABLET in 1 BOTTLE (67296-1226-1) 21 tablet2019-10-290000-00-00NoNoCurrent