FDA.reportPublic FDA data

valacyclovir hydrochloride

Product NDC
59746-325
11-digit product format
597460325
Labeler code
59746
Product ID
59746-325_40211dd2-c21e-45a4-a8d4-04febf925f52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA201506
Marketing category
ANDA
Marketing start
2012-04-05
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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313564, 313565

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
59746-325-012023-02-27C16284748780-1f386c649-bac0-0266-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
59746-325-102023-02-27C16284748780-1f386c649-bac0-0266-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
59746-325-302023-02-27C16284748780-1f386c649-bac0-0266-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
59746-325-372023-02-27C16284748780-1f386c649-bac0-0266-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
59746-325-472023-02-27C16284748780-1f386c649-bac0-0266-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
59746-325-902023-02-27C16284748780-1f386c649-bac0-0266-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
59746-325-012023-01-30C16284748780-1f386c649-bac0-0266-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
59746-325-102023-01-30C16284748780-1f386c649-bac0-0266-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
59746-325-302023-01-30C16284748780-1f386c649-bac0-0266-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
59746-325-372023-01-30C16284748780-1f386c649-bac0-0266-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
59746-325-472023-01-30C16284748780-1f386c649-bac0-0266-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
59746-325-902023-01-30C16284748780-1f386c649-bac0-0266-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
59746-325-01valacyclovir hydrochloride100 in 1 BOTTLETABLET, FILM COATED10015
59746-325-10valacyclovir hydrochloride10 in 1 BOTTLETABLET, FILM COATED1015
59746-325-30valacyclovir hydrochloride30 in 1 BOTTLETABLET, FILM COATED3015
59746-325-37valacyclovir hydrochloride250 in 1 BOTTLETABLET, FILM COATED25015
59746-325-47valacyclovir hydrochloride300 in 1 BOTTLETABLET, FILM COATED30015
59746-325-90valacyclovir hydrochloride90 in 1 BOTTLETABLET, FILM COATED9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-325-30EA - Each59746-325ab763180-75dc-42b9-9234-8f5330f872a812013-02-13
59746-325-37EA - Each59746-32543375c07-2a05-4ab5-bd1e-93b12199541a12013-02-13
59746-325-90EA - Each59746-32559bf553b-fb68-4a1c-b2d8-7ef89ea33b5712024-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
AcyclovirACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
HypromellosesINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AVALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]3
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
AcyclovirACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-325VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 6 package rows20230904_3277c17e-f953-2b0a-fe0a-4f5d1aeace9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN3277c17e-f953-2b0a-fe0a-4f5d1aeace9d15
313565valACYclovir 500 MG Oral TabletPSN3277c17e-f953-2b0a-fe0a-4f5d1aeace9d15
313564valacyclovir 1000 MG Oral TabletSCD3277c17e-f953-2b0a-fe0a-4f5d1aeace9d15
313565valacyclovir 500 MG Oral TabletSCD3277c17e-f953-2b0a-fe0a-4f5d1aeace9d15
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY3277c17e-f953-2b0a-fe0a-4f5d1aeace9d15
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY3277c17e-f953-2b0a-fe0a-4f5d1aeace9d15
313564valacyclovir 1 GM Oral TabletSY3277c17e-f953-2b0a-fe0a-4f5d1aeace9d15
197313acyclovir 800 MG Oral TabletPSN97a10bb6-52c0-495d-e053-2995a90a60a48
313564valACYclovir 1 GM Oral TabletPSN97a10bb6-52c0-495d-e053-2995a90a60a48
197313acyclovir 800 MG Oral TabletSCD97a10bb6-52c0-495d-e053-2995a90a60a48
313564valacyclovir 1000 MG Oral TabletSCD97a10bb6-52c0-495d-e053-2995a90a60a48
197313acycycloguanosine 800 MG Oral TabletSY97a10bb6-52c0-495d-e053-2995a90a60a48
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY97a10bb6-52c0-495d-e053-2995a90a60a48
313564valacyclovir 1 GM Oral TabletSY97a10bb6-52c0-495d-e053-2995a90a60a48
313564valACYclovir 1 GM Oral TabletPSN8853428e-2690-1ef6-e053-2a95a90a0a4b6
313564valacyclovir 1000 MG Oral TabletSCD8853428e-2690-1ef6-e053-2a95a90a0a4b6
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8853428e-2690-1ef6-e053-2a95a90a0a4b6
313564valacyclovir 1 GM Oral TabletSY8853428e-2690-1ef6-e053-2a95a90a0a4b6
313564valACYclovir 1 GM Oral TabletPSNff737ccb-91da-41b7-a105-e9a91f8f65825
313564valacyclovir 1000 MG Oral TabletSCDff737ccb-91da-41b7-a105-e9a91f8f65825
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYff737ccb-91da-41b7-a105-e9a91f8f65825
313564valacyclovir 1 GM Oral TabletSYff737ccb-91da-41b7-a105-e9a91f8f65825
313564valACYclovir 1 GM Oral TabletPSNad17b820-e9b9-407b-94e1-614073feb6dd4
313565valACYclovir 500 MG Oral TabletPSNad17b820-e9b9-407b-94e1-614073feb6dd4
313564valacyclovir 1000 MG Oral TabletSCDad17b820-e9b9-407b-94e1-614073feb6dd4
313565valacyclovir 500 MG Oral TabletSCDad17b820-e9b9-407b-94e1-614073feb6dd4
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYad17b820-e9b9-407b-94e1-614073feb6dd4
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYad17b820-e9b9-407b-94e1-614073feb6dd4
313564valacyclovir 1 GM Oral TabletSYad17b820-e9b9-407b-94e1-614073feb6dd4
313564valACYclovir 1 GM Oral TabletPSNefe37bd1-a236-43cc-828c-b57e8a704d673
313564valacyclovir 1000 MG Oral TabletSCDefe37bd1-a236-43cc-828c-b57e8a704d673
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYefe37bd1-a236-43cc-828c-b57e8a704d673
313564valacyclovir 1 GM Oral TabletSYefe37bd1-a236-43cc-828c-b57e8a704d673
313564valACYclovir 1 GM Oral TabletPSN1ea0a3ac-8876-48c1-e054-00144ff8d46c1
313564valacyclovir 1000 MG Oral TabletSCD1ea0a3ac-8876-48c1-e054-00144ff8d46c1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1ea0a3ac-8876-48c1-e054-00144ff8d46c1
313564valacyclovir 1 GM Oral TabletSY1ea0a3ac-8876-48c1-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-325-0159746032501100 TABLET, FILM COATED in 1 BOTTLE (59746-325-01) 2012-04-050000-00-00NoNoCurrent
59746-325-105974603251010 TABLET, FILM COATED in 1 BOTTLE (59746-325-10) 2012-04-050000-00-00NoNoCurrent
59746-325-305974603253030 TABLET, FILM COATED in 1 BOTTLE (59746-325-30) 2012-04-050000-00-00NoNoCurrent
59746-325-3759746032537250 TABLET, FILM COATED in 1 BOTTLE (59746-325-37) 2012-04-050000-00-00NoNoCurrent
59746-325-4759746032547300 TABLET, FILM COATED in 1 BOTTLE (59746-325-47) 2012-04-050000-00-00NoNoCurrent
59746-325-905974603259090 TABLET, FILM COATED in 1 BOTTLE (59746-325-90) 2012-04-050000-00-00NoNoCurrent