FDA.reportPublic FDA data

Valacyclovir

Product NDC
68788-8705
11-digit product format
687888705
Labeler code
68788
Product ID
68788-8705_b4046250-4f62-4395-8cd0-cdd31edca208
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209553
Marketing category
ANDA
Marketing start
2024-07-01
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1000 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1000 mg/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
68788-8705-0Valacyclovir6 in 1 BOTTLETABLET62
68788-8705-1Valacyclovir10 in 1 BOTTLETABLET102
68788-8705-2Valacyclovir20 in 1 BOTTLETABLET202
68788-8705-3Valacyclovir30 in 1 BOTTLETABLET302
68788-8705-4Valacyclovir4 in 1 BOTTLETABLET42
68788-8705-5Valacyclovir15 in 1 BOTTLETABLET152
68788-8705-7Valacyclovir21 in 1 BOTTLETABLET212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8705-0EA - Each68788-8705aac90d3c-785e-40a7-95a2-9e333843fcd712024-09-09
68788-8705-1EA - Each68788-8705b8aa68b2-a22f-4d0c-9cf3-60ae87f951a112024-09-09
68788-8705-2EA - Each68788-8705ad798236-0ecc-4585-9ae3-9331dfa1a8ba12024-09-09
68788-8705-3EA - Each68788-8705c9cb317c-5e1c-457a-8cd8-7d831cd7274912024-09-09
68788-8705-4EA - Each68788-8705cb7fdac8-aa91-4419-9945-0a1d1304e0ca12024-09-09
68788-8705-5EA - Each68788-870563f04fb6-82b8-4e90-89d6-7d068577d34212024-09-09
68788-8705-7EA - Each68788-870500cf1885-d78e-46c8-a5ac-842be8bba36012024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8705VALACYCLOVIR TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 7 package rows20240709_3146e367-8438-4141-9368-95ce6f59c724.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN3146e367-8438-4141-9368-95ce6f59c7242
313564valacyclovir 1000 MG Oral TabletSCD3146e367-8438-4141-9368-95ce6f59c7242
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY3146e367-8438-4141-9368-95ce6f59c7242
313564valacyclovir 1 GM Oral TabletSY3146e367-8438-4141-9368-95ce6f59c7242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8705-0687888705006 TABLET in 1 BOTTLE (68788-8705-0) 6 tablet2024-07-01NoNoHistorical
68788-8705-16878887050110 TABLET in 1 BOTTLE (68788-8705-1) 10 tablet2024-07-01NoNoHistorical
68788-8705-26878887050220 TABLET in 1 BOTTLE (68788-8705-2) 20 tablet2024-07-01NoNoHistorical
68788-8705-36878887050330 TABLET in 1 BOTTLE (68788-8705-3) 30 tablet2024-07-01NoNoHistorical
68788-8705-4687888705044 TABLET in 1 BOTTLE (68788-8705-4) 4 tablet2024-07-01NoNoHistorical
68788-8705-56878887050515 TABLET in 1 BOTTLE (68788-8705-5) 15 tablet2024-07-01NoNoHistorical
68788-8705-76878887050721 TABLET in 1 BOTTLE (68788-8705-7) 21 tablet2024-07-01NoNoHistorical