FDA.reportPublic FDA data

Valacyclovir

Product NDC
63187-950
11-digit product format
631870950
Labeler code
63187
Product ID
63187-950_441151ec-31f4-413c-8764-11fc16fb2ada
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
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

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
63187-950-04Valacyclovir4 in 1 BOTTLETABLET, FILM COATED46
63187-950-06Valacyclovir6 in 1 BOTTLETABLET, FILM COATED66
63187-950-10Valacyclovir10 in 1 BOTTLETABLET, FILM COATED106
63187-950-14Valacyclovir14 in 1 BOTTLETABLET, FILM COATED146
63187-950-20Valacyclovir20 in 1 BOTTLETABLET, FILM COATED206
63187-950-21Valacyclovir21 in 1 BOTTLETABLET, FILM COATED216
63187-950-30Valacyclovir30 in 1 BOTTLETABLET, FILM COATED306
63187-950-60Valacyclovir60 in 1 BOTTLETABLET, FILM COATED606
63187-950-90Valacyclovir90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-950VALACYCLOVIR TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 9 package rows20230927_8794a786-245a-42a3-b33a-9b0ed1dd46ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN8794a786-245a-42a3-b33a-9b0ed1dd46ac6
313564valacyclovir 1000 MG Oral TabletSCD8794a786-245a-42a3-b33a-9b0ed1dd46ac6
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8794a786-245a-42a3-b33a-9b0ed1dd46ac6
313564valacyclovir 1 GM Oral TabletSY8794a786-245a-42a3-b33a-9b0ed1dd46ac6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-950-04631870950044 TABLET, FILM COATED in 1 BOTTLE (63187-950-04) 2018-01-010000-00-00NoNoCurrent
63187-950-06631870950066 TABLET, FILM COATED in 1 BOTTLE (63187-950-06) 2018-01-010000-00-00NoNoCurrent
63187-950-106318709501010 TABLET, FILM COATED in 1 BOTTLE (63187-950-10) 2023-07-25NoNoCurrent
63187-950-146318709501414 TABLET, FILM COATED in 1 BOTTLE (63187-950-14) 2018-01-010000-00-00NoNoCurrent
63187-950-206318709502020 TABLET, FILM COATED in 1 BOTTLE (63187-950-20) 2023-09-25NoNoCurrent
63187-950-216318709502121 TABLET, FILM COATED in 1 BOTTLE (63187-950-21) 2018-01-010000-00-00NoNoCurrent
63187-950-306318709503030 TABLET, FILM COATED in 1 BOTTLE (63187-950-30) 2018-01-010000-00-00NoNoCurrent
63187-950-606318709506060 TABLET, FILM COATED in 1 BOTTLE (63187-950-60) 2018-01-010000-00-00NoNoCurrent
63187-950-906318709509090 TABLET, FILM COATED in 1 BOTTLE (63187-950-90) 2018-01-010000-00-00NoNoCurrent