FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
82868-055
11-digit product format
828680055
Labeler code
82868
Product ID
82868-055_46dcc5db-2924-de8f-e063-6394a90a101f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078518
Marketing category
ANDA
Marketing start
2024-05-30
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 Hydrochloride
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
82868-055-21Valacyclovir Hydrochloride21 in 1 BOTTLE, PLASTICTABLET, FILM COATED212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-055VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20240627_1b53c6bb-0e8c-f49a-e063-6294a90a0f5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN1b53c6bb-0e8c-f49a-e063-6294a90a0f5a2
313565valacyclovir 500 MG Oral TabletSCD1b53c6bb-0e8c-f49a-e063-6294a90a0f5a2
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY1b53c6bb-0e8c-f49a-e063-6294a90a0f5a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82868-055-218286800552121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-055-21) 2024-05-30NoNoHistorical