FDA.reportPublic FDA data

VALTREX

Product NDC
67296-0200
11-digit product format
672960200
Labeler code
67296
Product ID
67296-0200_d5fbf428-e6ed-0abc-e053-2a95a90a694d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug
Application
NDA020487
Marketing category
NDA
Marketing start
2002-08-12
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
67296-0200-12024-01-30C16284748780-11030e364-fe70-111a-e063-dadaa90a10e2Valtrex 1gm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0200-1VALTREX21 in 1 BOTTLETABLET, FILM COATED214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0200VALTREX (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG]4Legacy NDC, 1 package rows20220120_b2d1c6ad-e2ef-6b0d-e053-2a95a90a8d09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448VALTREX 1 GM Oral TabletPSNb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448valacyclovir 1000 MG Oral Tablet [Valtrex]SBDb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
313564valacyclovir 1000 MG Oral TabletSCDb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
313564valacyclovir 1 GM Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448Valtrex (as valacyclovir hydrochloride) 1000 MG Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448Valtrex 1 GM Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094
212448Valtrex 1000 MG Oral TabletSYb2d1c6ad-e2ef-6b0d-e053-2a95a90a8d094

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0200-16729602000121 TABLET, FILM COATED in 1 BOTTLE (67296-0200-1) 2002-08-120000-00-00NoNoCurrent