FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
50090-5852
11-digit product format
500905852
Labeler code
50090
Product ID
50090-5852_2b66c036-f48b-46b9-ade2-a0dc4e8a6f34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5852-02023-02-07C16284748780-1f386c649-e326-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
50090-5852-12023-02-07C16284748780-1f386c649-e326-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
50090-5852-22023-02-07C16284748780-1f386c649-e326-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
50090-5852-32023-02-07C16284748780-1f386c649-e326-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
50090-5852-02023-01-30C16284748780-1f386c649-e326-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
50090-5852-12023-01-30C16284748780-1f386c649-e326-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
50090-5852-22023-01-30C16284748780-1f386c649-e326-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
50090-5852-32023-01-30C16284748780-1f386c649-e326-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5852-0Valacyclovir Hydrochloride10 in 1 BOTTLETABLET, FILM COATED109
50090-5852-1Valacyclovir Hydrochloride14 in 1 BOTTLETABLET, FILM COATED149
50090-5852-2Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED309
50090-5852-3Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5852-0EA - Each50090-58520c98c41d-516c-4052-83ed-5e7d6ea7534c12022-07-06
50090-5852-1EA - Each50090-585299f628a7-362f-491a-a1f7-b9f4cbd12b2c12022-07-06
50090-5852-2EA - Each50090-585274f3585e-5d57-4b83-85d0-0dc59823388912022-06-06
50090-5852-3EA - Each50090-585253052540-d3e7-497c-a00e-9c7dd542a58c12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5852VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 4 package rows20250403_df34e11d-5f2c-4755-b84b-b95d1d7b73f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNdf34e11d-5f2c-4755-b84b-b95d1d7b73f09
313565valacyclovir 500 MG Oral TabletSCDdf34e11d-5f2c-4755-b84b-b95d1d7b73f09
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYdf34e11d-5f2c-4755-b84b-b95d1d7b73f09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5852-05009058520010 TABLET, FILM COATED in 1 BOTTLE (50090-5852-0) 2021-11-100000-00-00NoNoCurrent
50090-5852-15009058520114 TABLET, FILM COATED in 1 BOTTLE (50090-5852-1) 2021-11-100000-00-00NoNoCurrent
50090-5852-25009058520230 TABLET, FILM COATED in 1 BOTTLE (50090-5852-2) 2021-11-100000-00-00NoNoCurrent
50090-5852-35009058520390 TABLET, FILM COATED in 1 BOTTLE (50090-5852-3) 2021-11-100000-00-00NoNoCurrent