FDA.reportPublic FDA data

Valacyclovir

Product NDC
50090-6581
11-digit product format
500906581
Labeler code
50090
Product ID
50090-6581_2505ce8d-2867-49e4-a2bb-2ca1188af4d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209553
Marketing category
ANDA
Marketing start
2023-02-14
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
50090-6581-0Valacyclovir10 in 1 BOTTLETABLET101
50090-6581-1Valacyclovir14 in 1 BOTTLETABLET141
50090-6581-2Valacyclovir30 in 1 BOTTLETABLET301
50090-6581-3Valacyclovir90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6581-0EA - Each50090-6581e0dd5a23-44c7-4859-81cb-e0c8587ee29a12023-09-05
50090-6581-1EA - Each50090-658157dab339-a7db-4a6c-9f09-6b076e52f34312023-09-05
50090-6581-2EA - Each50090-65816e56a971-e161-457c-8b90-bd7c72ae94e412023-09-05
50090-6581-3EA - Each50090-65811b0b996e-d26e-4315-96b4-c39b39ea1d4112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6581VALACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20230810_659a7c36-378a-4392-bb13-948337caf17f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN659a7c36-378a-4392-bb13-948337caf17f1
313565valacyclovir 500 MG Oral TabletSCD659a7c36-378a-4392-bb13-948337caf17f1
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY659a7c36-378a-4392-bb13-948337caf17f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6581-05009065810010 TABLET in 1 BOTTLE (50090-6581-0) 10 tablet2023-08-07NoNoHistorical
50090-6581-15009065810114 TABLET in 1 BOTTLE (50090-6581-1) 14 tablet2023-08-07NoNoHistorical
50090-6581-25009065810230 TABLET in 1 BOTTLE (50090-6581-2) 30 tablet2023-08-07NoNoHistorical
50090-6581-35009065810390 TABLET in 1 BOTTLE (50090-6581-3) 90 tablet2023-08-07NoNoHistorical