FDA.reportPublic FDA data

Valacyclovir

Product NDC
69367-262
11-digit product format
693670262
Labeler code
69367
Product ID
69367-262_0d49baa9-8b27-4d4c-b57a-802a337565f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valacyclovir
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313564, 313565

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
69367-262-09Valacyclovir90 in 1 BOTTLETABLET904
69367-262-30Valacyclovir30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-262-09EA - Each69367-262d98d24f4-f615-4e48-863f-c69d15a8e5a212023-04-07
69367-262-30EA - Each69367-2628f82ef56-2d42-4115-b4fe-1b813be8291712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-262VALACYCLOVIR TABLET [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20230301_4bd97421-1e0a-40a6-a66b-f5f14e827eb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313565valACYclovir 500 MG Oral TabletPSN4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313564valacyclovir 1000 MG Oral TabletSCD4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313565valacyclovir 500 MG Oral TabletSCD4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313564valacyclovir 1 GM Oral TabletSY4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313565valACYclovir 500 MG Oral TabletPSN387c9c12-4735-1f9d-e063-6394a90a030c3
313565valacyclovir 500 MG Oral TabletSCD387c9c12-4735-1f9d-e063-6394a90a030c3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY387c9c12-4735-1f9d-e063-6394a90a030c3
313564valACYclovir 1 GM Oral TabletPSNa3a6a874-f568-429d-96b4-8ef89393564f2
313565valACYclovir 500 MG Oral TabletPSNa3a6a874-f568-429d-96b4-8ef89393564f2
313564valacyclovir 1000 MG Oral TabletSCDa3a6a874-f568-429d-96b4-8ef89393564f2
313565valacyclovir 500 MG Oral TabletSCDa3a6a874-f568-429d-96b4-8ef89393564f2
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYa3a6a874-f568-429d-96b4-8ef89393564f2
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYa3a6a874-f568-429d-96b4-8ef89393564f2
313564valacyclovir 1 GM Oral TabletSYa3a6a874-f568-429d-96b4-8ef89393564f2
313565valACYclovir 500 MG Oral TabletPSN659a7c36-378a-4392-bb13-948337caf17f1
313565valACYclovir 500 MG Oral TabletPSN65d13d0e-cf7f-4422-81f1-3dfce47227181
313565valACYclovir 500 MG Oral TabletPSN6ff2068f-1002-4d84-bd65-081d5b4082b11
313565valACYclovir 500 MG Oral TabletPSN890f45c7-191b-4d60-8c52-ed92c2319eb31
313565valacyclovir 500 MG Oral TabletSCD890f45c7-191b-4d60-8c52-ed92c2319eb31
313565valacyclovir 500 MG Oral TabletSCD659a7c36-378a-4392-bb13-948337caf17f1
313565valacyclovir 500 MG Oral TabletSCD6ff2068f-1002-4d84-bd65-081d5b4082b11
313565valacyclovir 500 MG Oral TabletSCD65d13d0e-cf7f-4422-81f1-3dfce47227181
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY890f45c7-191b-4d60-8c52-ed92c2319eb31
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY6ff2068f-1002-4d84-bd65-081d5b4082b11
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY65d13d0e-cf7f-4422-81f1-3dfce47227181
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
69367-262-096936702620990 TABLET in 1 BOTTLE (69367-262-09) 90 tablet2023-02-14NoNoHistorical
69367-262-306936702623030 TABLET in 1 BOTTLE (69367-262-30) 30 tablet2023-02-14NoNoHistorical