FDA.reportPublic FDA data

Valacyclovir

Product NDC
72189-594
11-digit product format
721890594
Labeler code
72189
Product ID
72189-594_410c1df4-2156-d672-e063-6394a90ab376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Direct _Rx
Application
ANDA209553
Marketing category
ANDA
Marketing start
2024-11-11
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

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
72189-594-04Valacyclovir4 in 1 BOTTLETABLET44
72189-594-16Valacyclovir16 in 1 BOTTLETABLET164
72189-594-21Valacyclovir21 in 1 BOTTLETABLET214
72189-594-30Valacyclovir30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-594-04EA - Each72189-59472d02aff-2abc-4c07-8606-0cb7b370a61712025-11-13
72189-594-16EA - Each72189-594a8ec9822-c2be-4c55-9b5e-5a8ddebd10bf12024-12-10
72189-594-21EA - Each72189-59476964be5-807c-46b3-af43-ae9ede57ef4d12024-12-10
72189-594-30EA - Each72189-59460847c1f-812c-4c27-b55e-b6b2f175205212024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-594VALACYCLOVIR TABLET [DIRECT _RX]3Current NDC, 4 package rows20241121_26a43531-c62a-9e7f-e063-6394a90a8d3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN26a43531-c62a-9e7f-e063-6394a90a8d3f4
313564valacyclovir 1000 MG Oral TabletSCD26a43531-c62a-9e7f-e063-6394a90a8d3f4
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY26a43531-c62a-9e7f-e063-6394a90a8d3f4
313564valacyclovir 1 GM Oral TabletSY26a43531-c62a-9e7f-e063-6394a90a8d3f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-594-04721890594044 TABLET in 1 BOTTLE (72189-594-04) 4 tablet2024-11-11NoNoCurrent
72189-594-167218905941616 TABLET in 1 BOTTLE (72189-594-16) 16 tablet2024-11-11NoNoCurrent
72189-594-217218905942121 TABLET in 1 BOTTLE (72189-594-21) 21 tablet2024-11-11NoNoCurrent
72189-594-307218905943030 TABLET in 1 BOTTLE (72189-594-30) 30 tablet2024-11-11NoNoCurrent