FDA.reportPublic FDA data

Valacyclovir

Product NDC
69117-0011
11-digit product format
691170011
Labeler code
69117
Product ID
69117-0011_47237b45-ce93-292b-e063-6394a90a1ab5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Yiling Pharmaceutical, Inc.
Application
ANDA209553
Marketing category
ANDA
Marketing start
2018-10-01
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, 313565

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
69117-0011-1Valacyclovir30 in 1 BOTTLETABLET309
69117-0011-2Valacyclovir90 in 1 BOTTLETABLET909
69117-0011-3Valacyclovir500 in 1 BOTTLETABLET5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0011VALACYCLOVIR TABLET VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) TABLET [YILING PHARMACEUTICAL, INC.]8Current NDC, Legacy NDC, 3 package rows20250101_f3ee4017-a4fc-475d-a49b-b39168ec5966.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNf3ee4017-a4fc-475d-a49b-b39168ec59669
313565valACYclovir 500 MG Oral TabletPSNf3ee4017-a4fc-475d-a49b-b39168ec59669
313564valacyclovir 1000 MG Oral TabletSCDf3ee4017-a4fc-475d-a49b-b39168ec59669
313565valacyclovir 500 MG Oral TabletSCDf3ee4017-a4fc-475d-a49b-b39168ec59669
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYf3ee4017-a4fc-475d-a49b-b39168ec59669
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYf3ee4017-a4fc-475d-a49b-b39168ec59669
313564valacyclovir 1 GM Oral TabletSYf3ee4017-a4fc-475d-a49b-b39168ec59669

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69117-0011-16911700110130 TABLET in 1 BOTTLE (69117-0011-1) 30 tablet2018-10-010000-00-00NoNoCurrent
69117-0011-26911700110290 TABLET in 1 BOTTLE (69117-0011-2) 90 tablet2018-10-010000-00-00NoNoCurrent
69117-0011-369117001103500 TABLET in 1 BOTTLE (69117-0011-3) 500 tablet2018-10-010000-00-00NoNoCurrent