FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
50090-1173
11-digit product format
500901173
Labeler code
50090
Product ID
50090-1173_a893c0b3-de3b-446a-81a0-6507427bd7e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-1173-0Valacyclovir Hydrochloride15 in 1 BOTTLETABLET, FILM COATED1513
50090-1173-1Valacyclovir Hydrochloride21 in 1 BOTTLETABLET, FILM COATED2113
50090-1173-2Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3013
50090-1173-3Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1173VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 4 package rows20250523_8c0be4f6-2d11-41d4-8f57-4f8db9da60b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN8c0be4f6-2d11-41d4-8f57-4f8db9da60b213
313564valacyclovir 1000 MG Oral TabletSCD8c0be4f6-2d11-41d4-8f57-4f8db9da60b213
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8c0be4f6-2d11-41d4-8f57-4f8db9da60b213
313564valacyclovir 1 GM Oral TabletSY8c0be4f6-2d11-41d4-8f57-4f8db9da60b213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1173-05009011730015 TABLET, FILM COATED in 1 BOTTLE (50090-1173-0) 2014-11-280000-00-00NoNoCurrent
50090-1173-15009011730121 TABLET, FILM COATED in 1 BOTTLE (50090-1173-1) 2014-11-280000-00-00NoNoCurrent
50090-1173-25009011730230 TABLET, FILM COATED in 1 BOTTLE (50090-1173-2) 2014-11-280000-00-00NoNoCurrent
50090-1173-35009011730390 TABLET, FILM COATED in 1 BOTTLE (50090-1173-3) 2025-05-16NoNoCurrent