FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
72789-263
11-digit product format
727890263
Labeler code
72789
Product ID
72789-263_4bace031-383a-f25c-e063-6294a90a27da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090682
Marketing category
ANDA
Marketing start
2010-05-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valacyclovir Hydrochloride
Listing expiration
2027-12-31

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
72789-263-06Valacyclovir Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED625
72789-263-10Valacyclovir Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1025
72789-263-14Valacyclovir Hydrochloride14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1425
72789-263-28Valacyclovir Hydrochloride28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2825
72789-263-90Valacyclovir Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-263-06EA - Each72789-26378b3f52e-fab5-4c55-a908-729e233ad6ea12025-08-11
72789-263-10EA - Each72789-263e259ea8a-6976-4396-a92f-64580784f1af12023-02-06
72789-263-14EA - Each72789-26305b39fd1-a573-4f87-ac39-8a016138810c12024-01-04
72789-263-28EA - Each72789-263ba70f426-a510-4401-8f14-8cb465a6389c12025-05-14
72789-263-90EA - Each72789-263abc61e7c-4f25-4024-b780-b5b7a855bcde12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-263VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 5 package rows20250305_ae8d15a4-1ed5-4e3c-9672-0f4735322a1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNae8d15a4-1ed5-4e3c-9672-0f4735322a1c25
313565valacyclovir 500 MG Oral TabletSCDae8d15a4-1ed5-4e3c-9672-0f4735322a1c25
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYae8d15a4-1ed5-4e3c-9672-0f4735322a1c25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-263-06727890263066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-06) 2025-06-18NoNoHistorical
72789-263-107278902631010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-10) 2022-10-110000-00-00NoNoCurrent
72789-263-147278902631414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-14) 2023-12-04NoNoHistorical
72789-263-287278902632828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-28) 2025-03-03NoNoHistorical
72789-263-907278902639090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-263-90) 2022-07-200000-00-00NoNoCurrent