FDA.reportPublic FDA data

Valacyclovir

Product NDC
71335-2534
11-digit product format
713352534
Labeler code
71335
Product ID
71335-2534_415566e0-337e-421f-81ae-313f9f33c05c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209553
Marketing category
ANDA
Marketing start
2023-02-14
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
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 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
71335-2534-0Valacyclovir60 in 1 BOTTLETABLET601
71335-2534-1Valacyclovir30 in 1 BOTTLETABLET301
71335-2534-2Valacyclovir21 in 1 BOTTLETABLET211
71335-2534-3Valacyclovir20 in 1 BOTTLETABLET201
71335-2534-4Valacyclovir4 in 1 BOTTLETABLET41
71335-2534-5Valacyclovir10 in 1 BOTTLETABLET101
71335-2534-6Valacyclovir6 in 1 BOTTLETABLET61
71335-2534-7Valacyclovir15 in 1 BOTTLETABLET151
71335-2534-8Valacyclovir8 in 1 BOTTLETABLET81
71335-2534-9Valacyclovir90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2534-1EA - Each71335-253433dbfe19-c654-4c6f-80b1-0655d1d079d212025-07-08
71335-2534-2EA - Each71335-25345c550dfc-0313-4520-bd7d-e98ecf78b4cb12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2534VALACYCLOVIR TABLET [BRYANT RANCH PREPACK]1Current NDC, 10 package rows20241212_b713ebfb-096e-445e-ab15-129aca20fadf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNb713ebfb-096e-445e-ab15-129aca20fadf1
313564valacyclovir 1000 MG Oral TabletSCDb713ebfb-096e-445e-ab15-129aca20fadf1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYb713ebfb-096e-445e-ab15-129aca20fadf1
313564valacyclovir 1 GM Oral TabletSYb713ebfb-096e-445e-ab15-129aca20fadf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2534-07133525340060 TABLET in 1 BOTTLE (71335-2534-0) 60 tablet2024-12-10NoNoHistorical
71335-2534-17133525340130 TABLET in 1 BOTTLE (71335-2534-1) 30 tablet2024-12-10NoNoHistorical
71335-2534-27133525340221 TABLET in 1 BOTTLE (71335-2534-2) 21 tablet2024-12-10NoNoHistorical
71335-2534-37133525340320 TABLET in 1 BOTTLE (71335-2534-3) 20 tablet2024-12-10NoNoHistorical
71335-2534-4713352534044 TABLET in 1 BOTTLE (71335-2534-4) 4 tablet2024-12-10NoNoHistorical
71335-2534-57133525340510 TABLET in 1 BOTTLE (71335-2534-5) 10 tablet2024-12-10NoNoHistorical
71335-2534-6713352534066 TABLET in 1 BOTTLE (71335-2534-6) 6 tablet2024-12-10NoNoHistorical
71335-2534-77133525340715 TABLET in 1 BOTTLE (71335-2534-7) 15 tablet2024-12-10NoNoHistorical
71335-2534-8713352534088 TABLET in 1 BOTTLE (71335-2534-8) 8 tablet2024-12-10NoNoHistorical
71335-2534-97133525340990 TABLET in 1 BOTTLE (71335-2534-9) 90 tablet2024-12-10NoNoHistorical