FDA.reportPublic FDA data

Valacyclovir

Product NDC
70518-4100
11-digit product format
705184100
Labeler code
70518
Product ID
70518-4100_4c9a1905-a99c-3ba5-e063-6394a90ab5bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209553
Marketing category
ANDA
Marketing start
2024-06-12
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
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 HYDROCHLORIDE1000 mg/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
70518-4100-0Valacyclovir30 in 1 BOTTLE, PLASTICTABLET309
70518-4100-1Valacyclovir21 in 1 BOTTLE, PLASTICTABLET219
70518-4100-2Valacyclovir14 in 1 BOTTLE, PLASTICTABLET149
70518-4100-3Valacyclovir7 in 1 BOTTLE, PLASTICTABLET79
70518-4100-4Valacyclovir4 in 1 BOTTLE, PLASTICTABLET49
70518-4100-5Valacyclovir10 in 1 BOTTLE, PLASTICTABLET109
70518-4100-6Valacyclovir20 in 1 BOTTLE, PLASTICTABLET209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4100VALACYCLOVIR TABLET [REMEDYREPACK INC.]4Current NDC, 7 package rows20250406_5e39bf80-ada6-4194-bf3d-2c044c3389da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN5e39bf80-ada6-4194-bf3d-2c044c3389da9
313564valacyclovir 1000 MG Oral TabletSCD5e39bf80-ada6-4194-bf3d-2c044c3389da9
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY5e39bf80-ada6-4194-bf3d-2c044c3389da9
313564valacyclovir 1 GM Oral TabletSY5e39bf80-ada6-4194-bf3d-2c044c3389da9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4100-07051841000030 TABLET in 1 BOTTLE, PLASTIC (70518-4100-0) 30 tablet2024-06-12NoNoCurrent
70518-4100-17051841000121 in 1 BOTTLE, PLASTICHistorical
70518-4100-27051841000214 TABLET in 1 BOTTLE, PLASTIC (70518-4100-2) 14 tablet2024-06-12NoNoCurrent
70518-4100-3705184100037 TABLET in 1 BOTTLE, PLASTIC (70518-4100-3) 7 tablet2024-07-09NoNoCurrent
70518-4100-4705184100044 TABLET in 1 BOTTLE, PLASTIC (70518-4100-4) 4 tablet2024-08-04NoNoCurrent
70518-4100-57051841000510 TABLET in 1 BOTTLE, PLASTIC (70518-4100-5) 10 tablet2025-04-02NoNoCurrent
70518-4100-67051841000620 TABLET in 1 BOTTLE, PLASTIC (70518-4100-6) 20 tablet2025-08-23NoNoCurrent