FDA.reportPublic FDA data

Valacyclovir

Product NDC
69367-263
11-digit product format
693670263
Labeler code
69367
Product ID
69367-263_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
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
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 HYDROCHLORIDE1000 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
69367-263-09Valacyclovir90 in 1 BOTTLETABLET904
69367-263-30Valacyclovir30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-263-09EA - Each69367-2633bf95b9b-731c-47a0-b039-112d5404c55712023-04-07
69367-263-30EA - Each69367-26390cf3a81-e76e-49f1-8a99-9eb3b59da4b012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-263VALACYCLOVIR 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 TabletPSN5e39bf80-ada6-4194-bf3d-2c044c3389da9
313564valacyclovir 1000 MG Oral TabletSCD5e39bf80-ada6-4194-bf3d-2c044c3389da9
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY5e39bf80-ada6-4194-bf3d-2c044c3389da9
313564valacyclovir 1 GM Oral TabletSY5e39bf80-ada6-4194-bf3d-2c044c3389da9
313564valACYclovir 1 GM Oral TabletPSN3251a0f1-cbfd-c9d6-e063-6394a90a09a05
313564valacyclovir 1000 MG Oral TabletSCD3251a0f1-cbfd-c9d6-e063-6394a90a09a05
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY3251a0f1-cbfd-c9d6-e063-6394a90a09a05
313564valacyclovir 1 GM Oral TabletSY3251a0f1-cbfd-c9d6-e063-6394a90a09a05
313564valACYclovir 1 GM Oral TabletPSN26a43531-c62a-9e7f-e063-6394a90a8d3f4
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
313564valacyclovir 1000 MG Oral TabletSCD26a43531-c62a-9e7f-e063-6394a90a8d3f4
313565valacyclovir 500 MG Oral TabletSCD4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY26a43531-c62a-9e7f-e063-6394a90a8d3f4
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313564valacyclovir 1 GM Oral TabletSY4bd97421-1e0a-40a6-a66b-f5f14e827eb34
313564valacyclovir 1 GM Oral TabletSY26a43531-c62a-9e7f-e063-6394a90a8d3f4
313564valACYclovir 1 GM Oral TabletPSN3146e367-8438-4141-9368-95ce6f59c7242
313564valACYclovir 1 GM Oral TabletPSNa3a6a874-f568-429d-96b4-8ef89393564f2
313565valACYclovir 500 MG Oral TabletPSNa3a6a874-f568-429d-96b4-8ef89393564f2
313564valacyclovir 1000 MG Oral TabletSCD3146e367-8438-4141-9368-95ce6f59c7242
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 TabletSY3146e367-8438-4141-9368-95ce6f59c7242
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 TabletSY3146e367-8438-4141-9368-95ce6f59c7242
313564valacyclovir 1 GM Oral TabletSYa3a6a874-f568-429d-96b4-8ef89393564f2
313564valACYclovir 1 GM Oral TabletPSN5af8f909-ad53-480e-9176-43f95dcc218a1
313564valACYclovir 1 GM Oral TabletPSNb713ebfb-096e-445e-ab15-129aca20fadf1
313564valACYclovir 1 GM Oral TabletPSN1ac7a13e-3f30-e140-e063-6394a90aa09d1
313564valACYclovir 1 GM Oral TabletPSN6719e877-cff4-4be8-a352-8df0afa4f74c1
313564valacyclovir 1000 MG Oral TabletSCDb713ebfb-096e-445e-ab15-129aca20fadf1
313564valacyclovir 1000 MG Oral TabletSCD5af8f909-ad53-480e-9176-43f95dcc218a1
313564valacyclovir 1000 MG Oral TabletSCD6719e877-cff4-4be8-a352-8df0afa4f74c1
313564valacyclovir 1000 MG Oral TabletSCD1ac7a13e-3f30-e140-e063-6394a90aa09d1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY6719e877-cff4-4be8-a352-8df0afa4f74c1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY5af8f909-ad53-480e-9176-43f95dcc218a1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1ac7a13e-3f30-e140-e063-6394a90aa09d1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYb713ebfb-096e-445e-ab15-129aca20fadf1
313564valacyclovir 1 GM Oral TabletSY6719e877-cff4-4be8-a352-8df0afa4f74c1
313564valacyclovir 1 GM Oral TabletSY5af8f909-ad53-480e-9176-43f95dcc218a1
313564valacyclovir 1 GM Oral TabletSY1ac7a13e-3f30-e140-e063-6394a90aa09d1
313564valacyclovir 1 GM Oral TabletSYb713ebfb-096e-445e-ab15-129aca20fadf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-263-096936702630990 TABLET in 1 BOTTLE (69367-263-09) 90 tablet2023-02-14NoNoHistorical
69367-263-306936702633030 TABLET in 1 BOTTLE (69367-263-30) 30 tablet2023-02-14NoNoHistorical