FDA.reportPublic FDA data

valacyclovir hydrochloride

Product NDC
67296-1076
11-digit product format
672961076
Labeler code
67296
Product ID
67296-1076_b8d064ea-f36e-569d-e053-2995a90ab730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA201506
Marketing category
ANDA
Marketing start
2019-01-01
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
67296-1076-12023-01-30C16284748780-1f386c64a-1e10-0266-e053-dadaa90a7c1avalacyclovir 1gm
67296-1076-62023-01-30C16284748780-1f386c64a-1e10-0266-e053-dadaa90a7c1avalacyclovir 1gm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1076-1valacyclovir hydrochloride21 in 1 BOTTLETABLET, FILM COATED216
67296-1076-6valacyclovir hydrochloride6 in 1 BOTTLETABLET, FILM COATED66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1076VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]6Legacy NDC, 2 package rows20210114_8853428e-2690-1ef6-e053-2a95a90a0a4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN8853428e-2690-1ef6-e053-2a95a90a0a4b6
313564valacyclovir 1000 MG Oral TabletSCD8853428e-2690-1ef6-e053-2a95a90a0a4b6
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8853428e-2690-1ef6-e053-2a95a90a0a4b6
313564valacyclovir 1 GM Oral TabletSY8853428e-2690-1ef6-e053-2a95a90a0a4b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1076-16729610760121 TABLET, FILM COATED in 1 BOTTLE (67296-1076-1) 2019-01-010000-00-00NoNoCurrent
67296-1076-6672961076066 TABLET, FILM COATED in 1 BOTTLE (67296-1076-6) 2019-01-010000-00-00NoNoCurrent