FDA.reportPublic FDA data

Valacyclovir

Product NDC
82804-006
11-digit product format
828040006
Labeler code
82804
Product ID
82804-006_dcd80515-07e5-476c-b923-22bb48af61f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209553
Marketing category
ANDA
Marketing start
2023-02-14
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, 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
82804-006-06Valacyclovir6 in 1 BOTTLETABLET62
82804-006-10Valacyclovir10 in 1 BOTTLETABLET102
82804-006-21Valacyclovir21 in 1 BOTTLETABLET212
82804-006-30Valacyclovir30 in 1 BOTTLETABLET302
82804-006-60Valacyclovir60 in 1 BOTTLETABLET602
82804-006-90Valacyclovir90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-006-10EA - Each82804-006073e10ad-f8d6-4fa7-91ea-01281d15332212024-02-14
82804-006-30EA - Each82804-006e1cd7308-f146-4c00-a92d-d7ac65c2106212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-006VALACYCLOVIR TABLET [PROFICIENT RX LP]2Current NDC, 6 package rows20231228_a3a6a874-f568-429d-96b4-8ef89393564f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNa3a6a874-f568-429d-96b4-8ef89393564f2
313565valACYclovir 500 MG Oral TabletPSNa3a6a874-f568-429d-96b4-8ef89393564f2
313564valacyclovir 1000 MG Oral TabletSCDa3a6a874-f568-429d-96b4-8ef89393564f2
313565valacyclovir 500 MG Oral TabletSCDa3a6a874-f568-429d-96b4-8ef89393564f2
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYa3a6a874-f568-429d-96b4-8ef89393564f2
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYa3a6a874-f568-429d-96b4-8ef89393564f2
313564valacyclovir 1 GM Oral TabletSYa3a6a874-f568-429d-96b4-8ef89393564f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-006-06828040006066 TABLET in 1 BOTTLE (82804-006-06) 6 tablet2023-09-08NoNoCurrent
82804-006-108280400061010 TABLET in 1 BOTTLE (82804-006-10) 10 tablet2023-12-26NoNoCurrent
82804-006-218280400062121 TABLET in 1 BOTTLE (82804-006-21) 21 tablet2023-09-08NoNoCurrent
82804-006-308280400063030 TABLET in 1 BOTTLE (82804-006-30) 30 tablet2023-09-08NoNoCurrent
82804-006-608280400066060 TABLET in 1 BOTTLE (82804-006-60) 60 tablet2023-09-08NoNoCurrent
82804-006-908280400069090 TABLET in 1 BOTTLE (82804-006-90) 90 tablet2023-09-08NoNoCurrent