FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
16714-698
11-digit product format
167140698
Labeler code
16714
Product ID
16714-698_6b2156c4-0d81-4c53-b497-85ed8d7656d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valacyclovir Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313564, 313565

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
16714-698-01Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3020
16714-698-02Valacyclovir Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10020
16714-698-03Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-698-01EA - Each16714-698776f48d3-45bd-44d1-867a-43a7a57e63f112012-07-24
16714-698-02EA - Each16714-6986c316567-a467-48ab-be63-416c1d9279c912012-07-24
16714-698-03EA - Each16714-698f4c373f9-fa31-4062-a69b-873127d58afa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-698VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC]18Current NDC, Legacy NDC, 3 package rows20240110_4acf51de-26f7-42b2-8acc-61b800627ef3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN4acf51de-26f7-42b2-8acc-61b800627ef320
313565valACYclovir 500 MG Oral TabletPSN4acf51de-26f7-42b2-8acc-61b800627ef320
313564valacyclovir 1000 MG Oral TabletSCD4acf51de-26f7-42b2-8acc-61b800627ef320
313565valacyclovir 500 MG Oral TabletSCD4acf51de-26f7-42b2-8acc-61b800627ef320
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY4acf51de-26f7-42b2-8acc-61b800627ef320
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY4acf51de-26f7-42b2-8acc-61b800627ef320
313564valacyclovir 1 GM Oral TabletSY4acf51de-26f7-42b2-8acc-61b800627ef320
313565valACYclovir 500 MG Oral TabletPSNdf34e11d-5f2c-4755-b84b-b95d1d7b73f09
313565valacyclovir 500 MG Oral TabletSCDdf34e11d-5f2c-4755-b84b-b95d1d7b73f09
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYdf34e11d-5f2c-4755-b84b-b95d1d7b73f09
313565valACYclovir 500 MG Oral TabletPSN87ec59e3-c06a-4ca7-bc65-5b251263ab3b3
313565valacyclovir 500 MG Oral TabletSCD87ec59e3-c06a-4ca7-bc65-5b251263ab3b3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY87ec59e3-c06a-4ca7-bc65-5b251263ab3b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-698-011671406980130 TABLET, FILM COATED in 1 BOTTLE (16714-698-01) 2010-05-240000-00-00NoNoCurrent
16714-698-0216714069802100 TABLET, FILM COATED in 1 BOTTLE (16714-698-02) 2010-05-240000-00-00NoNoCurrent
16714-698-031671406980390 TABLET, FILM COATED in 1 BOTTLE (16714-698-03) 2010-05-240000-00-00NoNoCurrent