FDA.reportPublic FDA data

Valacyclovir

Product NDC
82804-212
11-digit product format
828040212
Labeler code
82804
Product ID
82804-212_3c661fa1-7134-43fd-8519-f8e7659ded98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
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
Listing expiration
2026-12-31

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
82804-212-06Valacyclovir6 in 1 BOTTLETABLET, FILM COATED63
82804-212-10Valacyclovir10 in 1 BOTTLETABLET, FILM COATED103
82804-212-30Valacyclovir30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-212VALACYCLOVIR TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20250501_90a67c02-edce-44aa-8d3a-d819313acc26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN90a67c02-edce-44aa-8d3a-d819313acc263
313565valacyclovir 500 MG Oral TabletSCD90a67c02-edce-44aa-8d3a-d819313acc263
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY90a67c02-edce-44aa-8d3a-d819313acc263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-212-06828040212066 TABLET, FILM COATED in 1 BOTTLE (82804-212-06) 2025-06-11NoNoCurrent
82804-212-108280402121010 TABLET, FILM COATED in 1 BOTTLE (82804-212-10) 2025-06-24NoNoCurrent
82804-212-308280402123030 TABLET, FILM COATED in 1 BOTTLE (82804-212-30) 2025-04-22NoNoCurrent