FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
70518-2266
11-digit product format
705182266
Labeler code
70518
Product ID
70518-2266_4dda4698-c1cb-5a78-e063-6394a90a081f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090682
Marketing category
ANDA
Marketing start
2019-08-15
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
500 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313565

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
70518-2266-0Valacyclovir Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3015
70518-2266-1Valacyclovir Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9015
70518-2266-2Valacyclovir Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3015
70518-2266-3Valacyclovir Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED615
70518-2266-4Valacyclovir Hydrochloride14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1415

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2266VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 5 package rows20250523_740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f15
313565valacyclovir 500 MG Oral TabletSCD740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f15
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2266-07051822660030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2266-0) 2019-08-150000-00-00NoNoCurrent
70518-2266-17051822660190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2266-1) 2021-05-260000-00-00NoNoCurrent
70518-2266-27051822660230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2266-2) 2021-07-060000-00-00NoNoCurrent
70518-2266-3705182266036 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2266-3) 2022-02-140000-00-00NoNoCurrent
70518-2266-47051822660414 in 1 BOTTLE, PLASTICHistorical