FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
85766-026
11-digit product format
857660026
Labeler code
85766
Product ID
85766-026_4a16992e-bbaa-c4b0-e063-6294a90af825
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
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
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 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
85766-026-01Valacyclovir Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
85766-026-02Valacyclovir Hydrochloride2 in 1 BOTTLETABLET, FILM COATED25
85766-026-04Valacyclovir Hydrochloride4 in 1 BOTTLETABLET, FILM COATED45
85766-026-05Valacyclovir Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5005
85766-026-06Valacyclovir Hydrochloride6 in 1 BOTTLETABLET, FILM COATED65
85766-026-07Valacyclovir Hydrochloride7 in 1 BOTTLETABLET, FILM COATED75
85766-026-10Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED105
85766-026-14Valacyclovir Hydrochloride14 in 1 BOTTLETABLET, FILM COATED145
85766-026-15Valacyclovir Hydrochloride15 in 1 BOTTLETABLET, FILM COATED155
85766-026-20Valacyclovir Hydrochloride20 in 1 BOTTLETABLET, FILM COATED205
85766-026-30Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
85766-026-55Valacyclovir Hydrochloride1500 in 1 BOTTLETABLET, FILM COATED15005
85766-026-60Valacyclovir Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
85766-026-90Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN458bb24a-4f97-4003-93cb-356906a432c95
313564valacyclovir 1000 MG Oral TabletSCD458bb24a-4f97-4003-93cb-356906a432c95
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY458bb24a-4f97-4003-93cb-356906a432c95
313564valacyclovir 1 GM Oral TabletSY458bb24a-4f97-4003-93cb-356906a432c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-026-0185766002601100 TABLET, FILM COATED in 1 BOTTLE (85766-026-01) 2025-08-05NoNoCurrent
85766-026-02857660026022 TABLET, FILM COATED in 1 BOTTLE (85766-026-02) 2025-08-05NoNoCurrent
85766-026-04857660026044 TABLET, FILM COATED in 1 BOTTLE (85766-026-04) 2025-08-05NoNoCurrent
85766-026-0585766002605500 TABLET, FILM COATED in 1 BOTTLE (85766-026-05) 2025-08-05NoNoCurrent
85766-026-06857660026066 TABLET, FILM COATED in 1 BOTTLE (85766-026-06) 2025-09-24NoNoCurrent
85766-026-07857660026077 TABLET, FILM COATED in 1 BOTTLE (85766-026-07) 2025-08-05NoNoCurrent
85766-026-108576600261010 TABLET, FILM COATED in 1 BOTTLE (85766-026-10) 2025-08-05NoNoCurrent
85766-026-148576600261414 TABLET, FILM COATED in 1 BOTTLE (85766-026-14) 2025-08-05NoNoCurrent
85766-026-158576600261515 TABLET, FILM COATED in 1 BOTTLE (85766-026-15) 2025-08-05NoNoCurrent
85766-026-208576600262020 TABLET, FILM COATED in 1 BOTTLE (85766-026-20) 2025-08-05NoNoCurrent
85766-026-308576600263030 TABLET, FILM COATED in 1 BOTTLE (85766-026-30) 2025-08-05NoNoCurrent
85766-026-55857660026551500 TABLET, FILM COATED in 1 BOTTLE (85766-026-55) 2025-08-05NoNoCurrent
85766-026-608576600266060 TABLET, FILM COATED in 1 BOTTLE (85766-026-60) 2025-08-05NoNoCurrent
85766-026-908576600269090 TABLET, FILM COATED in 1 BOTTLE (85766-026-90) 2025-08-05NoNoCurrent