FDA.reportPublic FDA data

Valacyclovir

Product NDC
70518-2402
11-digit product format
705182402
Labeler code
70518
Product ID
70518-2402_4def1240-9140-8d84-e063-6294a90a788f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203047
Marketing category
ANDA
Marketing start
2019-11-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valacyclovir
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313564

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2402-0Valacyclovir4 in 1 BOTTLE, PLASTICTABLET, FILM COATED414
70518-2402-1Valacyclovir4 in 1 BOTTLE, PLASTICTABLET, FILM COATED414
70518-2402-2Valacyclovir21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2114
70518-2402-3Valacyclovir15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1514
70518-2402-4Valacyclovir14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1414
70518-2402-5Valacyclovir7 in 1 BOTTLE, PLASTICTABLET, FILM COATED714
70518-2402-6Valacyclovir30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
70518-2402-7Valacyclovir7 in 1 BOTTLE, PLASTICTABLET, FILM COATED714

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2402VALACYCLOVIR TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 8 package rows20250216_7c332401-afb6-455b-b61a-ea108a377ef6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN7c332401-afb6-455b-b61a-ea108a377ef614
313564valacyclovir 1000 MG Oral TabletSCD7c332401-afb6-455b-b61a-ea108a377ef614
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY7c332401-afb6-455b-b61a-ea108a377ef614
313564valacyclovir 1 GM Oral TabletSY7c332401-afb6-455b-b61a-ea108a377ef614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2402-0705182402004 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2402-0) 2019-11-040000-00-00NoNoCurrent
70518-2402-1705182402014 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2402-1) 2022-10-140000-00-00NoNoCurrent
70518-2402-27051824020221 in 1 BOTTLE, PLASTICHistorical
70518-2402-37051824020315 in 1 BOTTLE, PLASTICHistorical
70518-2402-47051824020414 in 1 BOTTLE, PLASTICHistorical
70518-2402-5705182402057 in 1 BOTTLE, PLASTICHistorical
70518-2402-67051824020630 in 1 BOTTLE, PLASTICHistorical
70518-2402-7705182402077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2402-7) 2025-02-14NoNoCurrent