FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
57237-043
11-digit product format
572370043
Labeler code
57237
Product ID
57237-043_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
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-043-05Valacyclovir Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50010
57237-043-30Valacyclovir Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3010
57237-043-90Valacyclovir Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-043-30EA - Each57237-04384b9c2fc-8276-4db1-b4a8-0eb36d5e998a12014-04-03
57237-043-90EA - Each57237-0435f662e2c-527e-4c59-b594-f1f170ed480912014-04-03

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
57237-043VALACYCLOVIR 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
313564valACYclovir 1 GM Oral TabletPSN4619bcc6-0070-4f3b-9cf9-900f3e5f7b19103
313564valacyclovir 1000 MG Oral TabletSCD4619bcc6-0070-4f3b-9cf9-900f3e5f7b19103
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY4619bcc6-0070-4f3b-9cf9-900f3e5f7b19103
313564valacyclovir 1 GM Oral TabletSY4619bcc6-0070-4f3b-9cf9-900f3e5f7b19103
313564valACYclovir 1 GM Oral TabletPSN8d1645c0-fd03-4992-9372-98026a26b3af10
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
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8d1645c0-fd03-4992-9372-98026a26b3af10
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 TabletPSNde96c14b-cd74-46dd-bcce-d1fa640a60378
313564valacyclovir 1000 MG Oral TabletSCDde96c14b-cd74-46dd-bcce-d1fa640a60378
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYde96c14b-cd74-46dd-bcce-d1fa640a60378
313564valacyclovir 1 GM Oral TabletSYde96c14b-cd74-46dd-bcce-d1fa640a60378
313564valACYclovir 1 GM Oral TabletPSN1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valACYclovir 1 GM Oral TabletPSN8022eb52-da04-eb0a-e053-2a91aa0a6f877
313565valACYclovir 500 MG Oral TabletPSN1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir 1000 MG Oral TabletSCD1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir 1000 MG Oral TabletSCD8022eb52-da04-eb0a-e053-2a91aa0a6f877
313565valacyclovir 500 MG Oral TabletSCD1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8022eb52-da04-eb0a-e053-2a91aa0a6f877
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valacyclovir 1 GM Oral TabletSY8022eb52-da04-eb0a-e053-2a91aa0a6f877
313564valacyclovir 1 GM Oral TabletSY1ef0f51a-f730-435c-bc0d-2175fee91a9e7
313564valACYclovir 1 GM Oral TabletPSN268af320-810a-48de-9a08-9850be2878e36
313564valacyclovir 1000 MG Oral TabletSCD268af320-810a-48de-9a08-9850be2878e36
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY268af320-810a-48de-9a08-9850be2878e36
313564valacyclovir 1 GM Oral TabletSY268af320-810a-48de-9a08-9850be2878e36
313564valACYclovir 1 GM Oral TabletPSN802308ed-8c26-fed5-e053-2a91aa0a42b05
313564valacyclovir 1000 MG Oral TabletSCD802308ed-8c26-fed5-e053-2a91aa0a42b05
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY802308ed-8c26-fed5-e053-2a91aa0a42b05
313564valacyclovir 1 GM Oral TabletSY802308ed-8c26-fed5-e053-2a91aa0a42b05
313564valACYclovir 1 GM Oral TabletPSN552b806d-97d2-364d-e054-00144ff8d46c4
313564valACYclovir 1 GM Oral TabletPSNf98aea50-e4d9-c0cc-e053-6294a90a811c4
313564valacyclovir 1000 MG Oral TabletSCDf98aea50-e4d9-c0cc-e053-6294a90a811c4
313564valacyclovir 1000 MG Oral TabletSCD552b806d-97d2-364d-e054-00144ff8d46c4
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSYf98aea50-e4d9-c0cc-e053-6294a90a811c4
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY552b806d-97d2-364d-e054-00144ff8d46c4
313564valacyclovir 1 GM Oral TabletSYf98aea50-e4d9-c0cc-e053-6294a90a811c4
313564valacyclovir 1 GM Oral TabletSY552b806d-97d2-364d-e054-00144ff8d46c4
313564valACYclovir 1 GM Oral TabletPSN95ad932a-0a49-6100-e053-2995a90a78483
313565valACYclovir 500 MG Oral TabletPSN95ad932a-0a49-6100-e053-2995a90a78483
313564valacyclovir 1000 MG Oral TabletSCD95ad932a-0a49-6100-e053-2995a90a78483
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 TabletSY95ad932a-0a49-6100-e053-2995a90a78483
313564valacyclovir 1 GM Oral TabletSY95ad932a-0a49-6100-e053-2995a90a78483
313564valACYclovir 1 GM Oral TabletPSN8422aeeb-0c3b-478d-82fb-ca051809db012
313564valacyclovir 1000 MG Oral TabletSCD8422aeeb-0c3b-478d-82fb-ca051809db012
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY8422aeeb-0c3b-478d-82fb-ca051809db012
313564valacyclovir 1 GM Oral TabletSY8422aeeb-0c3b-478d-82fb-ca051809db012
313564valACYclovir 1 GM Oral TabletPSN275c0198-10a5-139e-e063-6394a90a72be1
313564valacyclovir 1000 MG Oral TabletSCD275c0198-10a5-139e-e063-6394a90a72be1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY275c0198-10a5-139e-e063-6394a90a72be1
313564valacyclovir 1 GM Oral TabletSY275c0198-10a5-139e-e063-6394a90a72be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-043-0557237004305500 TABLET, FILM COATED in 1 BOTTLE (57237-043-05) 2010-05-240000-00-00NoNoCurrent
57237-043-305723700433030 TABLET, FILM COATED in 1 BOTTLE (57237-043-30) 2010-05-240000-00-00NoNoCurrent
57237-043-905723700439090 TABLET, FILM COATED in 1 BOTTLE (57237-043-90) 2010-05-240000-00-00NoNoCurrent