FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
0904-6565
11-digit product format
009046565
Labeler code
0904
Product ID
0904-6565_eb8216dd-b1bc-4e57-a5ac-3dfb8fb49e0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
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
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
0904-6565-07Valacyclovir Hydrochloride30 in 1 CARTONTABLET, FILM COATED3010
0904-6565-07Valacyclovir Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED110
0904-6565-61Valacyclovir Hydrochloride100 in 1 CARTONTABLET, FILM COATED10010
0904-6565-61Valacyclovir Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6565-07EA - Each0904-6565dc773e2f-ecc4-4852-b99b-24c9d4ac113912017-08-11
0904-6565-61EA - Each0904-6565e382251d-e34f-4839-8dd8-98ced34f139212017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6565VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 4 package rows20250110_fd982aee-d503-47b3-8d3d-42e9a8690457.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313565valACYclovir 500 MG Oral TabletPSNfd982aee-d503-47b3-8d3d-42e9a869045710
313565valacyclovir 500 MG Oral TabletSCDfd982aee-d503-47b3-8d3d-42e9a869045710
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSYfd982aee-d503-47b3-8d3d-42e9a869045710
313565valACYclovir 500 MG Oral TabletPSN72300f70-57fd-42a8-a2dc-4cf95a1ce8055
313565valacyclovir 500 MG Oral TabletSCD72300f70-57fd-42a8-a2dc-4cf95a1ce8055
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY72300f70-57fd-42a8-a2dc-4cf95a1ce8055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6565-070090465650730 BLISTER PACK in 1 CARTON (0904-6565-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2010-05-240000-00-00NoNoCurrent
0904-6565-6100904656561100 BLISTER PACK in 1 CARTON (0904-6565-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2010-05-240000-00-00NoNoCurrent