FDA.reportPublic FDA data

Valacyclovir Hydrochloride

Product NDC
43063-730
11-digit product format
430630730
Labeler code
43063
Product ID
43063-730_51a5c9d3-30dc-519b-e063-6394a90a1e07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
Rxcui313565

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
43063-730-10Valacyclovir Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1020
43063-730-14Valacyclovir Hydrochloride14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1420
43063-730-90Valacyclovir Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-730-10EA - Each43063-7301838600b-df45-4bbd-ad1e-07650d33674212017-03-06
43063-730-14EA - Each43063-730c3efaaa9-7732-45f6-bb2f-f02a612fe2c712017-03-06
43063-730-90EA - Each43063-73039b3601f-3509-443e-a304-65b2d0c433bf12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-730VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 3 package rows20240607_1a888812-2867-4dd3-b56e-2d98da837d1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-730-104306307301010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-10) 2017-01-190000-00-00NoNoCurrent
43063-730-144306307301414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-14) 2016-11-290000-00-00NoNoCurrent
43063-730-904306307309090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-730-90) 2019-02-080000-00-00NoNoCurrent