FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
68788-8820
11-digit product format
687888820
Labeler code
68788
Product ID
68788-8820_52ea1a06-965e-476f-bb5b-e672b50102ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090682
Marketing category
ANDA
Marketing start
2025-01-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valacyclovir Hydrochloride
Listing expiration
2026-12-31

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
68788-8820-0Valacyclovir Hydrochloride6 in 1 BOTTLETABLET, FILM COATED62
68788-8820-1Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED102
68788-8820-2Valacyclovir Hydrochloride20 in 1 BOTTLETABLET, FILM COATED202
68788-8820-3Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
68788-8820-4Valacyclovir Hydrochloride4 in 1 BOTTLETABLET, FILM COATED42
68788-8820-5Valacyclovir Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152
68788-8820-7Valacyclovir Hydrochloride21 in 1 BOTTLETABLET, FILM COATED212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8820-0EA - Each68788-882009e6fc45-61e9-4930-aa98-b1006f5cfc6112025-03-04
68788-8820-1EA - Each68788-8820f52eb754-9b10-4aa5-957a-83680e6e149d12025-03-04
68788-8820-2EA - Each68788-88205298c550-3f84-4a74-b937-8ce62bd7d9b312025-03-04
68788-8820-3EA - Each68788-88203b5bb49d-d49e-4ff1-bae0-be02a49d8c1412025-03-04
68788-8820-4EA - Each68788-882061fe380b-a8a6-4e02-a1b2-6751ec0ef96512025-03-04
68788-8820-5EA - Each68788-88207cb361ff-d825-4d46-9626-a4fbf59c29c812025-03-04
68788-8820-7EA - Each68788-88209170f90f-109f-45f5-81e2-2c2bbeed49b812025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8820VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 7 package rows20250205_8422aeeb-0c3b-478d-82fb-ca051809db01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN8422aeeb-0c3b-478d-82fb-ca051809db012
313564valacyclovir 1000 MG Oral TabletSCD8422aeeb-0c3b-478d-82fb-ca051809db012
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8422aeeb-0c3b-478d-82fb-ca051809db012
313564valacyclovir 1 GM Oral TabletSY8422aeeb-0c3b-478d-82fb-ca051809db012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8820-0687888820006 TABLET, FILM COATED in 1 BOTTLE (68788-8820-0) 2025-01-23NoNoCurrent
68788-8820-16878888200110 TABLET, FILM COATED in 1 BOTTLE (68788-8820-1) 2025-01-23NoNoCurrent
68788-8820-26878888200220 TABLET, FILM COATED in 1 BOTTLE (68788-8820-2) 2025-01-23NoNoCurrent
68788-8820-36878888200330 TABLET, FILM COATED in 1 BOTTLE (68788-8820-3) 2025-01-23NoNoCurrent
68788-8820-4687888820044 TABLET, FILM COATED in 1 BOTTLE (68788-8820-4) 2025-01-23NoNoCurrent
68788-8820-56878888200515 TABLET, FILM COATED in 1 BOTTLE (68788-8820-5) 2025-01-23NoNoCurrent
68788-8820-76878888200721 TABLET, FILM COATED in 1 BOTTLE (68788-8820-7) 2025-01-23NoNoCurrent