FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
63187-776
11-digit product format
631870776
Labeler code
63187
Product ID
63187-776_e5dca408-5050-47da-a6c8-fb75a79cc86e
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
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
63187-776-04Valacyclovir Hydrochloride04 in 1 BOTTLETABLET, FILM COATED046
63187-776-10Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED106
63187-776-14Valacyclovir Hydrochloride14 in 1 BOTTLETABLET, FILM COATED146
63187-776-20Valacyclovir Hydrochloride20 in 1 BOTTLETABLET, FILM COATED206
63187-776-21Valacyclovir Hydrochloride21 in 1 BOTTLETABLET, FILM COATED216
63187-776-30Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
63187-776-60Valacyclovir Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
63187-776-90Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-776-04EA - Each63187-7769cfbbacd-9d69-4a19-983d-14a6aae62cb912017-07-07
63187-776-10EA - Each63187-776ac5f9a29-854f-42a3-a741-b5435593931f12020-03-10
63187-776-14EA - Each63187-776bdad5606-2c15-4e5f-bd56-de5f09af98d512020-03-10
63187-776-20EA - Each63187-7762faa783d-20fd-4d49-bcb6-7e54e2b4afaa12020-04-20
63187-776-21EA - Each63187-77659ef7017-ec69-4cfc-b674-bd73154a3da712017-07-07
63187-776-30EA - Each63187-77671075aea-53b1-438e-8519-eb2bd5df41b012017-04-05
63187-776-90EA - Each63187-776d87d7add-5004-4df7-9c2f-6aed3ca612e212020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-776VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 8 package rows20220402_268af320-810a-48de-9a08-9850be2878e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN268af320-810a-48de-9a08-9850be2878e36
313564valacyclovir 1000 MG Oral TabletSCD268af320-810a-48de-9a08-9850be2878e36
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY268af320-810a-48de-9a08-9850be2878e36
313564valacyclovir 1 GM Oral TabletSY268af320-810a-48de-9a08-9850be2878e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-776-04631870776044 TABLET, FILM COATED in 1 BOTTLE (63187-776-04) 2016-12-010000-00-00NoNoCurrent
63187-776-106318707761010 TABLET, FILM COATED in 1 BOTTLE (63187-776-10) 2019-11-210000-00-00NoNoCurrent
63187-776-146318707761414 TABLET, FILM COATED in 1 BOTTLE (63187-776-14) 2019-11-210000-00-00NoNoCurrent
63187-776-206318707762020 TABLET, FILM COATED in 1 BOTTLE (63187-776-20) 2020-02-050000-00-00NoNoCurrent
63187-776-216318707762121 TABLET, FILM COATED in 1 BOTTLE (63187-776-21) 2016-11-010000-00-00NoNoCurrent
63187-776-306318707763030 TABLET, FILM COATED in 1 BOTTLE (63187-776-30) 2016-11-010000-00-00NoNoCurrent
63187-776-606318707766060 TABLET, FILM COATED in 1 BOTTLE (63187-776-60) 2016-11-010000-00-00NoNoCurrent
63187-776-906318707769090 TABLET, FILM COATED in 1 BOTTLE (63187-776-90) 2016-11-010000-00-00NoNoCurrent