FDA.reportPublic FDA data

valacyclovir hydrochloride

Product NDC
63187-538
11-digit product format
631870538
Labeler code
63187
Product ID
63187-538_0ac3f14c-c375-408e-a1d7-8412e3420a40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201506
Marketing category
ANDA
Marketing start
2012-04-05
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 hydrochloride
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-538-04valacyclovir hydrochloride4 in 1 BOTTLETABLET, FILM COATED43
63187-538-14valacyclovir hydrochloride14 in 1 BOTTLETABLET, FILM COATED143
63187-538-30valacyclovir hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
63187-538-60valacyclovir hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
63187-538-90valacyclovir hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-538VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20200128_efe37bd1-a236-43cc-828c-b57e8a704d67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNefe37bd1-a236-43cc-828c-b57e8a704d673
313564valacyclovir 1000 MG Oral TabletSCDefe37bd1-a236-43cc-828c-b57e8a704d673
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYefe37bd1-a236-43cc-828c-b57e8a704d673
313564valacyclovir 1 GM Oral TabletSYefe37bd1-a236-43cc-828c-b57e8a704d673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-538-04631870538044 TABLET, FILM COATED in 1 BOTTLE (63187-538-04) 2015-09-010000-00-00NoNoCurrent
63187-538-146318705381414 TABLET, FILM COATED in 1 BOTTLE (63187-538-14) 2015-09-010000-00-00NoNoCurrent
63187-538-306318705383030 TABLET, FILM COATED in 1 BOTTLE (63187-538-30) 2015-09-010000-00-00NoNoCurrent
63187-538-606318705386060 TABLET, FILM COATED in 1 BOTTLE (63187-538-60) 2015-09-010000-00-00NoNoCurrent
63187-538-906318705389090 TABLET, FILM COATED in 1 BOTTLE (63187-538-90) 2015-09-010000-00-00NoNoCurrent