FDA.reportPublic FDA data

Valacyclovir

Product NDC
68071-4805
11-digit product format
680714805
Labeler code
68071
Product ID
68071-4805_4f70a224-a1fa-2b68-e063-6394a90a38bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare 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
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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4805-12024-03-21C16284748780-1ba0f9c33-25b1-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
68071-4805-12023-01-30C16284748780-1ba0f9c33-25b1-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
68071-4805-12021-02-17C16284748780-1ba0f9c33-25b1-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995
68071-4805-12021-01-29C16284748780-1ba0f9c33-25b1-a910-e053-dadaa90a0b85HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Tablets, USP Initial U.S. Approval:1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4805-1Valacyclovir90 in 1 BOTTLETABLET, FILM COATED905
68071-4805-3Valacyclovir30 in 1 BOTTLETABLET, FILM COATED305
68071-4805-6Valacyclovir60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4805VALACYCLOVIR TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 3 package rows20240616_84601168-8829-f4a3-e053-2991aa0a3c20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN84601168-8829-f4a3-e053-2991aa0a3c205
313564valacyclovir 1000 MG Oral TabletSCD84601168-8829-f4a3-e053-2991aa0a3c205
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY84601168-8829-f4a3-e053-2991aa0a3c205
313564valacyclovir 1 GM Oral TabletSY84601168-8829-f4a3-e053-2991aa0a3c205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4805-16807148050190 TABLET, FILM COATED in 1 BOTTLE (68071-4805-1) 2019-03-180000-00-00NoNoCurrent
68071-4805-36807148050330 TABLET, FILM COATED in 1 BOTTLE (68071-4805-3) 2026-04-14NoNoCurrent
68071-4805-66807148050660 TABLET, FILM COATED in 1 BOTTLE (68071-4805-6) 2019-03-18NoNoCurrent