FDA.reportPublic FDA data

Valacyclovir

Product NDC
71335-0630
11-digit product format
713350630
Labeler code
71335
Product ID
71335-0630_375e88d9-f545-4d58-bad6-f0281802d93c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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 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
71335-0630-0Valacyclovir60 in 1 BOTTLETABLET, FILM COATED609
71335-0630-1Valacyclovir30 in 1 BOTTLETABLET, FILM COATED309
71335-0630-2Valacyclovir21 in 1 BOTTLETABLET, FILM COATED219
71335-0630-3Valacyclovir20 in 1 BOTTLETABLET, FILM COATED209
71335-0630-4Valacyclovir4 in 1 BOTTLETABLET, FILM COATED49
71335-0630-5Valacyclovir10 in 1 BOTTLETABLET, FILM COATED109
71335-0630-6Valacyclovir6 in 1 BOTTLETABLET, FILM COATED69
71335-0630-7Valacyclovir15 in 1 BOTTLETABLET, FILM COATED159
71335-0630-8Valacyclovir8 in 1 BOTTLETABLET, FILM COATED89
71335-0630-9Valacyclovir90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0630-1EA - Each71335-0630931c41d5-76ca-4fdf-91ad-d6087898920512018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0630VALACYCLOVIR (VALACYCLOVIR) TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 10 package rows20240830_e5f5223f-569c-40c6-a3c7-381bc61cf8c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSNe5f5223f-569c-40c6-a3c7-381bc61cf8c69
313564valacyclovir 1000 MG Oral TabletSCDe5f5223f-569c-40c6-a3c7-381bc61cf8c69
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYe5f5223f-569c-40c6-a3c7-381bc61cf8c69
313564valacyclovir 1 GM Oral TabletSYe5f5223f-569c-40c6-a3c7-381bc61cf8c69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0630-07133506300060 TABLET, FILM COATED in 1 BOTTLE (71335-0630-0) 2021-10-050000-00-00NoNoCurrent
71335-0630-17133506300130 TABLET, FILM COATED in 1 BOTTLE (71335-0630-1) 2018-05-290000-00-00NoNoCurrent
71335-0630-27133506300221 TABLET, FILM COATED in 1 BOTTLE (71335-0630-2) 2018-03-210000-00-00NoNoCurrent
71335-0630-37133506300320 TABLET, FILM COATED in 1 BOTTLE (71335-0630-3) 2018-07-240000-00-00NoNoCurrent
71335-0630-4713350630044 TABLET, FILM COATED in 1 BOTTLE (71335-0630-4) 2018-07-130000-00-00NoNoCurrent
71335-0630-57133506300510 TABLET, FILM COATED in 1 BOTTLE (71335-0630-5) 2019-05-280000-00-00NoNoCurrent
71335-0630-6713350630066 TABLET, FILM COATED in 1 BOTTLE (71335-0630-6) 2018-03-200000-00-00NoNoCurrent
71335-0630-77133506300715 TABLET, FILM COATED in 1 BOTTLE (71335-0630-7) 2019-03-040000-00-00NoNoCurrent
71335-0630-8713350630088 TABLET, FILM COATED in 1 BOTTLE (71335-0630-8) 2018-05-290000-00-00NoNoCurrent
71335-0630-97133506300990 TABLET, FILM COATED in 1 BOTTLE (71335-0630-9) 2020-02-180000-00-00NoNoCurrent