FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
49483-691
11-digit product format
494830691
Labeler code
49483
Product ID
49483-691_c715d9f2-9fe1-0bdd-e053-2a95a90aecf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC.
Application
ANDA079012
Marketing category
ANDA
Marketing start
2021-07-14
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, 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
49483-691-01Valacyclovir Hydrochloride100 in 1 BOTTLETABLET1003
49483-691-03Valacyclovir Hydrochloride30 in 1 BOTTLETABLET303
49483-691-04Valacyclovir Hydrochloride10 in 1 BLISTER PACKTABLET103
49483-691-50Valacyclovir Hydrochloride500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-691VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET [TIME CAP LABORATORIES, INC.]3Current NDC, Legacy NDC, 4 package rows20210719_c33a2a36-16d3-4a35-e053-2995a90af240.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNc33a2a36-16d3-4a35-e053-2995a90af2403
313565valACYclovir 500 MG Oral TabletPSNc33a2a36-16d3-4a35-e053-2995a90af2403
313564valacyclovir 1000 MG Oral TabletSCDc33a2a36-16d3-4a35-e053-2995a90af2403
313565valacyclovir 500 MG Oral TabletSCDc33a2a36-16d3-4a35-e053-2995a90af2403
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYc33a2a36-16d3-4a35-e053-2995a90af2403
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYc33a2a36-16d3-4a35-e053-2995a90af2403
313564valacyclovir 1 GM Oral TabletSYc33a2a36-16d3-4a35-e053-2995a90af2403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-691-0149483069101100 TABLET in 1 BOTTLE (49483-691-01) 100 tablet2021-07-140000-00-00NoNoCurrent
49483-691-034948306910330 TABLET in 1 BOTTLE (49483-691-03) 30 tablet2021-07-140000-00-00NoNoCurrent
49483-691-044948306910410 TABLET in 1 BLISTER PACK (49483-691-04) 10 tablet2021-07-140000-00-00NoNoCurrent
49483-691-5049483069150500 TABLET in 1 BOTTLE (49483-691-50) 500 tablet2021-07-140000-00-00NoNoCurrent