FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
57237-042
11-digit product format
572370042
Labeler code
57237
Product ID
57237-042_a9ee543a-9c63-46df-99f9-cd085ce08bee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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
Rxcui313564, 313565

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
57237-042-05Valacyclovir Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50010
57237-042-30Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3010
57237-042-90Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-042-30EA - Each57237-0428a408e2a-35df-4ed1-a42a-58812ac16b9012014-04-03
57237-042-90EA - Each57237-0429ed10764-f24b-4fca-bfc0-89b8b59a211012014-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-042VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 3 package rows20240113_8d1645c0-fd03-4992-9372-98026a26b3af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNa56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d3100
313565valacyclovir 500 MG Oral TabletSCDa56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d3100
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYa56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d3100
313565valACYclovir 500 MG Oral TabletPSN1a888812-2867-4dd3-b56e-2d98da837d1f20
313565valacyclovir 500 MG Oral TabletSCD1a888812-2867-4dd3-b56e-2d98da837d1f20
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY1a888812-2867-4dd3-b56e-2d98da837d1f20
313565valACYclovir 500 MG Oral TabletPSN740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f15
313565valacyclovir 500 MG Oral TabletSCD740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f15
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f15
313565valACYclovir 500 MG Oral TabletPSN93dccd99-d28b-4c47-872c-c3c0001b8a7f11
313565valacyclovir 500 MG Oral TabletSCD93dccd99-d28b-4c47-872c-c3c0001b8a7f11
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY93dccd99-d28b-4c47-872c-c3c0001b8a7f11
313564valACYclovir 1 GM Oral TabletPSN8d1645c0-fd03-4992-9372-98026a26b3af10
313565valACYclovir 500 MG Oral TabletPSNfd982aee-d503-47b3-8d3d-42e9a869045710
313565valACYclovir 500 MG Oral TabletPSN8d1645c0-fd03-4992-9372-98026a26b3af10
313564valacyclovir 1000 MG Oral TabletSCD8d1645c0-fd03-4992-9372-98026a26b3af10
313565valacyclovir 500 MG Oral TabletSCD8d1645c0-fd03-4992-9372-98026a26b3af10
313565valacyclovir 500 MG Oral TabletSCDfd982aee-d503-47b3-8d3d-42e9a869045710
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8d1645c0-fd03-4992-9372-98026a26b3af10
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYfd982aee-d503-47b3-8d3d-42e9a869045710
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY8d1645c0-fd03-4992-9372-98026a26b3af10
313564valacyclovir 1 GM Oral TabletSY8d1645c0-fd03-4992-9372-98026a26b3af10
313564valACYclovir 1 GM Oral TabletPSN1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313565valACYclovir 500 MG Oral TabletPSN1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir 1000 MG Oral TabletSCD1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313565valacyclovir 500 MG Oral TabletSCD1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir 1 GM Oral TabletSY1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313565valACYclovir 500 MG Oral TabletPSNc6328ed5-a3d3-4948-94be-b226271d03116
313565valacyclovir 500 MG Oral TabletSCDc6328ed5-a3d3-4948-94be-b226271d03116
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYc6328ed5-a3d3-4948-94be-b226271d03116
313565valACYclovir 500 MG Oral TabletPSN82bac944-417a-0af7-e053-2a91aa0a86745
313565valacyclovir 500 MG Oral TabletSCD82bac944-417a-0af7-e053-2a91aa0a86745
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY82bac944-417a-0af7-e053-2a91aa0a86745
313564valACYclovir 1 GM Oral TabletPSN95ad932a-0a49-6100-e053-2995a90a78483
313565valACYclovir 500 MG Oral TabletPSN95ad932a-0a49-6100-e053-2995a90a78483
313565valACYclovir 500 MG Oral TabletPSNf32d5f04-4198-82a5-e053-2995a90a18413
313565valACYclovir 500 MG Oral TabletPSN883f643b-27f6-5a3e-e053-2995a90a8ff13
313565valACYclovir 500 MG Oral TabletPSN7681a6f4-a6e7-4277-adbd-38837d5ead6b3
313564valacyclovir 1000 MG Oral TabletSCD95ad932a-0a49-6100-e053-2995a90a78483
313565valacyclovir 500 MG Oral TabletSCD7681a6f4-a6e7-4277-adbd-38837d5ead6b3
313565valacyclovir 500 MG Oral TabletSCDf32d5f04-4198-82a5-e053-2995a90a18413
313565valacyclovir 500 MG Oral TabletSCD883f643b-27f6-5a3e-e053-2995a90a8ff13
313565valacyclovir 500 MG Oral TabletSCD95ad932a-0a49-6100-e053-2995a90a78483
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY95ad932a-0a49-6100-e053-2995a90a78483
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY883f643b-27f6-5a3e-e053-2995a90a8ff13
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY7681a6f4-a6e7-4277-adbd-38837d5ead6b3
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY95ad932a-0a49-6100-e053-2995a90a78483
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYf32d5f04-4198-82a5-e053-2995a90a18413
313564valacyclovir 1 GM Oral TabletSY95ad932a-0a49-6100-e053-2995a90a78483
313565valACYclovir 500 MG Oral TabletPSNb99b8309-dd80-422a-9b17-f20386dc4d8d1
313565valACYclovir 500 MG Oral TabletPSN82ddec27-79ac-40f4-afde-707f3940f8931
313565valacyclovir 500 MG Oral TabletSCDb99b8309-dd80-422a-9b17-f20386dc4d8d1
313565valacyclovir 500 MG Oral TabletSCD82ddec27-79ac-40f4-afde-707f3940f8931
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYb99b8309-dd80-422a-9b17-f20386dc4d8d1
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY82ddec27-79ac-40f4-afde-707f3940f8931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-042-0557237004205500 TABLET, FILM COATED in 1 BOTTLE (57237-042-05) 2010-05-240000-00-00NoNoCurrent
57237-042-305723700423030 TABLET, FILM COATED in 1 BOTTLE (57237-042-30) 2010-05-240000-00-00NoNoCurrent
57237-042-905723700429090 TABLET, FILM COATED in 1 BOTTLE (57237-042-90) 2010-05-240000-00-00NoNoCurrent