FDA.reportPublic FDA data

Valacyclovir

Product NDC
68071-3749
11-digit product format
680713749
Labeler code
68071
Product ID
68071-3749_2a09600d-c2fa-0a52-e063-6394a90a228c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
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
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 HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313565

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
68071-3749-4Valacyclovir14 in 1 BOTTLETABLET, FILM COATED142
68071-3749-6Valacyclovir6 in 1 BOTTLETABLET, FILM COATED61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3749VALACYCLOVIR TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20241226_29a6b4ec-3e23-289b-e063-6394a90a1157.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSN29a6b4ec-3e23-289b-e063-6394a90a11572
313565valacyclovir 500 MG Oral TabletSCD29a6b4ec-3e23-289b-e063-6394a90a11572
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY29a6b4ec-3e23-289b-e063-6394a90a11572
313565valACYclovir 500 MG Oral TabletPSN3aff1f5e-d92b-686b-e063-6294a90a29951
313565valacyclovir 500 MG Oral TabletSCD3aff1f5e-d92b-686b-e063-6294a90a29951
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY3aff1f5e-d92b-686b-e063-6294a90a29951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3749-46807137490414 TABLET, FILM COATED in 1 BOTTLE (68071-3749-4) 2024-12-19NoNoHistorical
68071-3749-6680713749066 TABLET, FILM COATED in 1 BOTTLE (68071-3749-6) 2025-07-28NoNoHistorical