FDA.reportPublic FDA data

Valacyclovir

Product NDC
72789-452
11-digit product format
727890452
Labeler code
72789
Product ID
72789-452_4d7b15fb-01ce-665a-e063-6294a90abf2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
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
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 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
72789-452-21Valacyclovir21 in 1 BOTTLE, PLASTICTABLET, FILM COATED217

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-452-21EA - Each72789-452de08396a-2713-4626-8b84-4f19b29f172412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-452VALACYCLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5Current NDC, 1 package rows20241120_e6f54a83-eb07-49d6-b93a-6fe94db323b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNe6f54a83-eb07-49d6-b93a-6fe94db323b87
313564valacyclovir 1000 MG Oral TabletSCDe6f54a83-eb07-49d6-b93a-6fe94db323b87
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYe6f54a83-eb07-49d6-b93a-6fe94db323b87
313564valacyclovir 1 GM Oral TabletSYe6f54a83-eb07-49d6-b93a-6fe94db323b87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-452-217278904522121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-452-21) 2024-11-18NoNoHistorical