FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
85766-054
11-digit product format
857660054
Labeler code
85766
Product ID
85766-054_502ee215-ab84-3c2c-e063-6294a90a2f73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm 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
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
85766-054-01Valacyclovir Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003
85766-054-02Valacyclovir Hydrochloride2 in 1 BOTTLETABLET, FILM COATED23
85766-054-04Valacyclovir Hydrochloride4 in 1 BOTTLETABLET, FILM COATED43
85766-054-07Valacyclovir Hydrochloride7 in 1 BOTTLETABLET, FILM COATED73
85766-054-10Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED103
85766-054-14Valacyclovir Hydrochloride14 in 1 BOTTLETABLET, FILM COATED143
85766-054-15Valacyclovir Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
85766-054-20Valacyclovir Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
85766-054-28Valacyclovir Hydrochloride28 in 1 BOTTLETABLET, FILM COATED283
85766-054-30Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
85766-054-60Valacyclovir Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
85766-054-90Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN7681a6f4-a6e7-4277-adbd-38837d5ead6b3
313565valacyclovir 500 MG Oral TabletSCD7681a6f4-a6e7-4277-adbd-38837d5ead6b3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY7681a6f4-a6e7-4277-adbd-38837d5ead6b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-054-0185766005401100 TABLET, FILM COATED in 1 BOTTLE (85766-054-01) 2025-08-17NoNoHistorical
85766-054-02857660054022 TABLET, FILM COATED in 1 BOTTLE (85766-054-02) 2025-08-17NoNoHistorical
85766-054-04857660054044 TABLET, FILM COATED in 1 BOTTLE (85766-054-04) 2025-08-17NoNoHistorical
85766-054-07857660054077 TABLET, FILM COATED in 1 BOTTLE (85766-054-07) 2025-08-17NoNoHistorical
85766-054-108576600541010 TABLET, FILM COATED in 1 BOTTLE (85766-054-10) 2025-08-17NoNoHistorical
85766-054-148576600541414 TABLET, FILM COATED in 1 BOTTLE (85766-054-14) 2025-08-17NoNoHistorical
85766-054-158576600541515 TABLET, FILM COATED in 1 BOTTLE (85766-054-15) 2025-08-17NoNoHistorical
85766-054-208576600542020 TABLET, FILM COATED in 1 BOTTLE (85766-054-20) 2025-08-17NoNoHistorical
85766-054-288576600542828 TABLET, FILM COATED in 1 BOTTLE (85766-054-28) 2025-10-23NoNoHistorical
85766-054-308576600543030 TABLET, FILM COATED in 1 BOTTLE (85766-054-30) 2025-08-17NoNoHistorical
85766-054-608576600546060 TABLET, FILM COATED in 1 BOTTLE (85766-054-60) 2025-08-17NoNoHistorical
85766-054-908576600549090 TABLET, FILM COATED in 1 BOTTLE (85766-054-90) 2025-08-17NoNoHistorical