FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
70518-0541
11-digit product format
705180541
Labeler code
70518
Product ID
70518-0541_47f7d1d0-101a-490e-e063-6394a90af266
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078518
Marketing category
ANDA
Marketing start
2017-05-15
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 Hydrochloride
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
70518-0541-0Valacyclovir Hydrochloride4 in 1 BOTTLE, PLASTICTABLET, FILM COATED410
70518-0541-1Valacyclovir Hydrochloride14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1410
70518-0541-2Valacyclovir Hydrochloride5 in 1 BOTTLE, PLASTICTABLET, FILM COATED510
70518-0541-3Valacyclovir Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2010
70518-0541-4Valacyclovir Hydrochloride4 in 1 BOTTLE, PLASTICTABLET, FILM COATED410
70518-0541-5Valacyclovir Hydrochloride5 in 1 BOTTLE, PLASTICTABLET, FILM COATED510

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN1ecd2332-4c60-46c1-a175-774926ffc6c610
313564valacyclovir 1000 MG Oral TabletSCD1ecd2332-4c60-46c1-a175-774926ffc6c610
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1ecd2332-4c60-46c1-a175-774926ffc6c610
313564valacyclovir 1 GM Oral TabletSY1ecd2332-4c60-46c1-a175-774926ffc6c610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-0541-0705180541004 in 1 BOTTLE, PLASTICHistorical
70518-0541-17051805410114 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0541-1) 2025-09-29NoNoCurrent
70518-0541-2705180541025 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0541-2) 2025-09-29NoNoCurrent
70518-0541-37051805410320 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0541-3) 2025-10-03NoNoCurrent
70518-0541-4705180541044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0541-4) 2025-10-30NoNoCurrent
70518-0541-5705180541055 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0541-5) 2025-10-30NoNoCurrent