FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
63187-832
11-digit product format
631870832
Labeler code
63187
Product ID
63187-832_2c2ca723-20ca-4aed-8579-528163d0505c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090682
Marketing category
ANDA
Marketing start
2010-05-24
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
500 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313565

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
63187-832-04Valacyclovir Hydrochloride4 in 1 BOTTLETABLET, FILM COATED46
63187-832-06Valacyclovir Hydrochloride6 in 1 BOTTLETABLET, FILM COATED66
63187-832-10Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED106
63187-832-14Valacyclovir Hydrochloride14 in 1 BOTTLETABLET, FILM COATED146
63187-832-21Valacyclovir Hydrochloride21 in 1 BOTTLETABLET, FILM COATED216
63187-832-28Valacyclovir Hydrochloride28 in 1 BOTTLETABLET, FILM COATED286
63187-832-30Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
63187-832-60Valacyclovir Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
63187-832-90Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-832-06EA - Each63187-832551584f0-41eb-422d-af28-3294abdb941f12017-06-15
63187-832-10EA - Each63187-8323bab4eeb-1796-464a-bece-7c8887976c7712018-10-11
63187-832-30EA - Each63187-83294bcec3f-5799-47a0-9e5f-ddaa7e73a13b12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-832VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 9 package rows20220513_c6328ed5-a3d3-4948-94be-b226271d0311.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNc6328ed5-a3d3-4948-94be-b226271d03116
313565valacyclovir 500 MG Oral TabletSCDc6328ed5-a3d3-4948-94be-b226271d03116
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYc6328ed5-a3d3-4948-94be-b226271d03116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-832-04631870832044 TABLET, FILM COATED in 1 BOTTLE (63187-832-04) 2017-04-030000-00-00NoNoCurrent
63187-832-06631870832066 TABLET, FILM COATED in 1 BOTTLE (63187-832-06) 2017-04-030000-00-00NoNoCurrent
63187-832-106318708321010 TABLET, FILM COATED in 1 BOTTLE (63187-832-10) 2018-07-020000-00-00NoNoCurrent
63187-832-146318708321414 TABLET, FILM COATED in 1 BOTTLE (63187-832-14) 2017-04-030000-00-00NoNoCurrent
63187-832-216318708322121 TABLET, FILM COATED in 1 BOTTLE (63187-832-21) 2017-04-030000-00-00NoNoCurrent
63187-832-286318708322828 TABLET, FILM COATED in 1 BOTTLE (63187-832-28) 2017-04-030000-00-00NoNoCurrent
63187-832-306318708323030 TABLET, FILM COATED in 1 BOTTLE (63187-832-30) 2017-04-030000-00-00NoNoCurrent
63187-832-606318708326060 TABLET, FILM COATED in 1 BOTTLE (63187-832-60) 2017-04-030000-00-00NoNoCurrent
63187-832-906318708329090 TABLET, FILM COATED in 1 BOTTLE (63187-832-90) 2017-04-030000-00-00NoNoCurrent