FDA.reportPublic FDA data

Valacyclovir

Product NDC
62135-613
11-digit product format
621350613
Labeler code
62135
Product ID
62135-613_459d28fe-0458-21de-e063-6394a90a6e87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA209553
Marketing category
ANDA
Marketing start
2018-10-01
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
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
62135-613-30Valacyclovir30 in 1 BOTTLETABLET303
62135-613-90Valacyclovir90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-613-30EA - Each62135-61337f6cbfe-0879-4400-b49c-1a3ea9c9699b12023-08-08
62135-613-90EA - Each62135-6139148ce9e-658f-4a7b-bf92-c387e4a252d412023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-613VALACYCLOVIR TABLET [CHARTWELL RX, LLC]2Current NDC, 2 package rows20241031_e59f15d0-c32a-4848-bdd5-fc2542e561c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNe59f15d0-c32a-4848-bdd5-fc2542e561c03
313565valACYclovir 500 MG Oral TabletPSNe59f15d0-c32a-4848-bdd5-fc2542e561c03
313564valacyclovir 1000 MG Oral TabletSCDe59f15d0-c32a-4848-bdd5-fc2542e561c03
313565valacyclovir 500 MG Oral TabletSCDe59f15d0-c32a-4848-bdd5-fc2542e561c03
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYe59f15d0-c32a-4848-bdd5-fc2542e561c03
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYe59f15d0-c32a-4848-bdd5-fc2542e561c03
313564valacyclovir 1 GM Oral TabletSYe59f15d0-c32a-4848-bdd5-fc2542e561c03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-613-306213506133030 TABLET in 1 BOTTLE (62135-613-30) 30 tablet2023-06-21NoNoHistorical
62135-613-906213506139090 TABLET in 1 BOTTLE (62135-613-90) 90 tablet2023-06-21NoNoHistorical