FDA.reportPublic FDA data

Valacyclovir

Product NDC
68788-7587
11-digit product format
687887587
Labeler code
68788
Product ID
68788-7587_c347cba6-fba8-4c16-9584-c79d6c2a8179
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valacyclovir
Listing expiration
2026-12-31

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
68788-7587-0Valacyclovir6 in 1 BOTTLETABLET, FILM COATED67
68788-7587-1Valacyclovir10 in 1 BOTTLETABLET, FILM COATED107
68788-7587-2Valacyclovir20 in 1 BOTTLETABLET, FILM COATED207
68788-7587-3Valacyclovir30 in 1 BOTTLETABLET, FILM COATED307
68788-7587-4Valacyclovir4 in 1 BOTTLETABLET, FILM COATED47
68788-7587-5Valacyclovir15 in 1 BOTTLETABLET, FILM COATED157
68788-7587-7Valacyclovir21 in 1 BOTTLETABLET, FILM COATED217

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7587VALACYCLOVIR TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 7 package rows20240824_7abc96b9-8f34-4fda-b5bb-1bdf23c1e135.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN7abc96b9-8f34-4fda-b5bb-1bdf23c1e1357
313564valacyclovir 1000 MG Oral TabletSCD7abc96b9-8f34-4fda-b5bb-1bdf23c1e1357
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY7abc96b9-8f34-4fda-b5bb-1bdf23c1e1357
313564valacyclovir 1 GM Oral TabletSY7abc96b9-8f34-4fda-b5bb-1bdf23c1e1357

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7587-0687887587006 TABLET, FILM COATED in 1 BOTTLE (68788-7587-0) 2019-12-270000-00-00NoNoCurrent
68788-7587-16878875870110 TABLET, FILM COATED in 1 BOTTLE (68788-7587-1) 2019-12-270000-00-00NoNoCurrent
68788-7587-26878875870220 TABLET, FILM COATED in 1 BOTTLE (68788-7587-2) 2019-12-270000-00-00NoNoCurrent
68788-7587-36878875870330 TABLET, FILM COATED in 1 BOTTLE (68788-7587-3) 2019-12-270000-00-00NoNoCurrent
68788-7587-4687887587044 TABLET, FILM COATED in 1 BOTTLE (68788-7587-4) 2019-12-270000-00-00NoNoCurrent
68788-7587-56878875870515 TABLET, FILM COATED in 1 BOTTLE (68788-7587-5) 2019-12-270000-00-00NoNoCurrent
68788-7587-76878875870721 TABLET, FILM COATED in 1 BOTTLE (68788-7587-7) 2019-12-270000-00-00NoNoCurrent