FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
68788-8904
11-digit product format
687888904
Labeler code
68788
Product ID
68788-8904_82ddec27-79ac-40f4-afde-707f3940f893
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090682
Marketing category
ANDA
Marketing start
2025-07-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
68788-8904-3Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
68788-8904-9Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8904-3EA - Each68788-89040e0d486c-1504-4eca-be48-7ad6271aee0612025-11-13
68788-8904-9EA - Each68788-8904fa850ea6-e6ba-4ff0-8b5a-4c63b96a324312025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN82ddec27-79ac-40f4-afde-707f3940f8931
313565valacyclovir 500 MG Oral TabletSCD82ddec27-79ac-40f4-afde-707f3940f8931
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY82ddec27-79ac-40f4-afde-707f3940f8931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8904-36878889040330 TABLET, FILM COATED in 1 BOTTLE (68788-8904-3) 2025-07-31NoNoCurrent
68788-8904-96878889040990 TABLET, FILM COATED in 1 BOTTLE (68788-8904-9) 2025-07-31NoNoCurrent