FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
50268-788
11-digit product format
502680788
Labeler code
50268
Product ID
50268-788_4138ca20-b94f-bdfd-e063-6294a90aa9d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA090682
Marketing category
ANDA
Marketing start
2014-09-22
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
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
50268-788-11Valacyclovir Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED17
50268-788-15Valacyclovir Hydrochloride50 in 1 BOX, UNIT-DOSETABLET, FILM COATED507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-788-11EA - Each50268-788ace104ba-01a2-4de2-b8ec-06ab1cb58cc012014-12-01
50268-788-15EA - Each50268-788f48e7448-50f4-4e42-a486-9e5bb70d5b6d12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-788VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]6Current NDC, Legacy NDC, 2 package rows20220507_7f5fc62f-d043-db36-ce92-7adc4f7a79a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313565valACYclovir 500 MG Oral TabletPSN7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313564valacyclovir 1000 MG Oral TabletSCD7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313565valacyclovir 500 MG Oral TabletSCD7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313564valacyclovir 1 GM Oral TabletSY7f5fc62f-d043-db36-ce92-7adc4f7a79a57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-788-11502680788111 in 1 BLISTER PACKHistorical
50268-788-155026807881550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-788-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-788-11) 50 blister pack2014-09-220000-00-00NoNoCurrent