FDA.reportPublic FDA data

Valacyclovir

Product NDC
43063-771
11-digit product format
430630771
Labeler code
43063
Product ID
43063-771_51cd3ad2-9d41-7180-e063-6394a90a05d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA203047
Marketing category
ANDA
Marketing start
2015-05-25
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG447S0T1VC
Rxcui313564

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
43063-771-06Valacyclovir6 in 1 BOTTLE, PLASTICTABLET, FILM COATED621
43063-771-14Valacyclovir14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1421
43063-771-20Valacyclovir20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2021
43063-771-21Valacyclovir21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-771VALACYCLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 4 package rows20250121_1b11361c-5444-498b-ab7c-fbad917705ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN1b11361c-5444-498b-ab7c-fbad917705ae21
313564valacyclovir 1000 MG Oral TabletSCD1b11361c-5444-498b-ab7c-fbad917705ae21
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY1b11361c-5444-498b-ab7c-fbad917705ae21
313564valacyclovir 1 GM Oral TabletSY1b11361c-5444-498b-ab7c-fbad917705ae21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-771-06430630771066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-06) 2017-06-080000-00-00NoNoCurrent
43063-771-144306307711414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-14) 2018-03-230000-00-00NoNoCurrent
43063-771-204306307712020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-20) 2018-03-200000-00-00NoNoCurrent
43063-771-214306307712121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-771-21) 2017-08-110000-00-00NoNoCurrent