FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
65862-448
11-digit product format
658620448
Labeler code
65862
Product ID
65862-448_aecf12c1-9094-48b6-8cb0-fcace52e191a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
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 HYDROCHLORIDE500 mg/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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-448-01Valacyclovir Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10017
65862-448-05Valacyclovir Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50017
65862-448-10Valacyclovir Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1017
65862-448-10Valacyclovir Hydrochloride10 in 1 CARTONTABLET, FILM COATED1017
65862-448-30Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3017
65862-448-35Valacyclovir Hydrochloride3500 in 1 BOTTLETABLET, FILM COATED350017
65862-448-90Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-448-30EA - Each65862-448fa7e6602-c4e5-4557-a9b3-9ab7fc793a3412012-07-24
65862-448-90EA - Each65862-4487181c216-a24e-43a3-a1f3-fc5dfe376e1912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
VALACYCLOVIR HYDROCHLORIDEACTIVE INGREDIENTG447S0T1VCVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-448VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]16Current NDC, Legacy NDC, 7 package rows20240109_f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5.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
313565valACYclovir 500 MG Oral TabletPSNe300970d-1145-4460-a8c8-f6e1654c2c3d20
313565valacyclovir 500 MG Oral TabletSCDe300970d-1145-4460-a8c8-f6e1654c2c3d20
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYe300970d-1145-4460-a8c8-f6e1654c2c3d20
313564valACYclovir 1 GM Oral TabletPSNf5cfb61e-d971-4a9c-b9ef-4f3368fe02f517
313565valACYclovir 500 MG Oral TabletPSNf5cfb61e-d971-4a9c-b9ef-4f3368fe02f517
313564valacyclovir 1000 MG Oral TabletSCDf5cfb61e-d971-4a9c-b9ef-4f3368fe02f517
313565valacyclovir 500 MG Oral TabletSCDf5cfb61e-d971-4a9c-b9ef-4f3368fe02f517
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYf5cfb61e-d971-4a9c-b9ef-4f3368fe02f517
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYf5cfb61e-d971-4a9c-b9ef-4f3368fe02f517
313564valacyclovir 1 GM Oral TabletSYf5cfb61e-d971-4a9c-b9ef-4f3368fe02f517
313564valACYclovir 1 GM Oral TabletPSN23fb4162-2310-486c-ba9f-f7c94b793e569
313565valACYclovir 500 MG Oral TabletPSN23fb4162-2310-486c-ba9f-f7c94b793e569
313564valacyclovir 1000 MG Oral TabletSCD23fb4162-2310-486c-ba9f-f7c94b793e569
313565valacyclovir 500 MG Oral TabletSCD23fb4162-2310-486c-ba9f-f7c94b793e569
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY23fb4162-2310-486c-ba9f-f7c94b793e569
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY23fb4162-2310-486c-ba9f-f7c94b793e569
313564valacyclovir 1 GM Oral TabletSY23fb4162-2310-486c-ba9f-f7c94b793e569
313564valACYclovir 1 GM Oral TabletPSN7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313564valACYclovir 1 GM Oral TabletPSN0ad6d733-ecbb-4578-962c-a88fd13e0f6c7
313565valACYclovir 500 MG Oral TabletPSN7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313565valACYclovir 500 MG Oral TabletPSN0ad6d733-ecbb-4578-962c-a88fd13e0f6c7
313564valacyclovir 1000 MG Oral TabletSCD7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313564valacyclovir 1000 MG Oral TabletSCD0ad6d733-ecbb-4578-962c-a88fd13e0f6c7
313565valacyclovir 500 MG Oral TabletSCD0ad6d733-ecbb-4578-962c-a88fd13e0f6c7
313565valacyclovir 500 MG Oral TabletSCD7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY0ad6d733-ecbb-4578-962c-a88fd13e0f6c7
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY0ad6d733-ecbb-4578-962c-a88fd13e0f6c7
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313564valacyclovir 1 GM Oral TabletSY0ad6d733-ecbb-4578-962c-a88fd13e0f6c7
313564valacyclovir 1 GM Oral TabletSY7f5fc62f-d043-db36-ce92-7adc4f7a79a57
313565valACYclovir 500 MG Oral TabletPSNe005139e-6f76-9b2f-e053-2a95a90ab0fb3
313565valacyclovir 500 MG Oral TabletSCDe005139e-6f76-9b2f-e053-2a95a90ab0fb3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYe005139e-6f76-9b2f-e053-2a95a90ab0fb3
313565valACYclovir 500 MG Oral TabletPSNf31c6018-4eee-fb52-e053-2995a90ae7641
313565valACYclovir 500 MG Oral TabletPSNe07f7cd0-53b5-9065-e053-2a95a90a0bc21
313565valacyclovir 500 MG Oral TabletSCDe07f7cd0-53b5-9065-e053-2a95a90a0bc21
313565valacyclovir 500 MG Oral TabletSCDf31c6018-4eee-fb52-e053-2995a90ae7641
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYe07f7cd0-53b5-9065-e053-2a95a90a0bc21
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYf31c6018-4eee-fb52-e053-2995a90ae7641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-448-0165862044801100 TABLET, FILM COATED in 1 BOTTLE (65862-448-01) 2010-05-240000-00-00NoNoCurrent
65862-448-0565862044805500 TABLET, FILM COATED in 1 BOTTLE (65862-448-05) 2010-05-240000-00-00NoNoCurrent
65862-448-106586204481010 BLISTER PACK in 1 CARTON (65862-448-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2010-05-240000-00-00NoNoCurrent
65862-448-306586204483030 TABLET, FILM COATED in 1 BOTTLE (65862-448-30) 2010-05-240000-00-00NoNoCurrent
65862-448-35658620448353500 TABLET, FILM COATED in 1 BOTTLE (65862-448-35) 2010-05-240000-00-00NoNoCurrent
65862-448-906586204489090 TABLET, FILM COATED in 1 BOTTLE (65862-448-90) 2010-05-240000-00-00NoNoCurrent