FDA.reportPublic FDA data

Valacyclovir

Product NDC
50090-7702
11-digit product format
500907702
Labeler code
50090
Product ID
50090-7702_f0f161b9-6f97-4b3c-ba62-a0ba54b11006
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
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
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
50090-7702-0Valacyclovir90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7702-0EA - Each50090-7702486aec08-6e1c-4bde-9450-6276ac832f7f12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN4ab809f3-8898-463c-b55a-f452c87d07794
313565valacyclovir 500 MG Oral TabletSCD4ab809f3-8898-463c-b55a-f452c87d07794
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY4ab809f3-8898-463c-b55a-f452c87d07794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7702-05009077020090 TABLET, FILM COATED in 1 BOTTLE (50090-7702-0) 2025-10-14NoNoHistorical