FDA.reportPublic FDA data

Valacyclovir

Product NDC
82009-041
11-digit product format
820090041
Labeler code
82009
Product ID
82009-041_48e59181-d597-f69b-e063-6294a90ad434
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA203047
Marketing category
ANDA
Marketing start
2022-10-14
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, 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
82009-041-90Valacyclovir90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-041-90EA - Each82009-041b86fa1f1-ff7a-43ce-8978-929414c023cc12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-041VALACYCLOVIR (VALACYCLOVIR) TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC]2Current NDC, Legacy NDC, 1 package rows20221029_764b0cf9-9207-404c-87a8-a1e0109af6cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN764b0cf9-9207-404c-87a8-a1e0109af6cc6
313565valACYclovir 500 MG Oral TabletPSN764b0cf9-9207-404c-87a8-a1e0109af6cc6
313564valacyclovir 1000 MG Oral TabletSCD764b0cf9-9207-404c-87a8-a1e0109af6cc6
313565valacyclovir 500 MG Oral TabletSCD764b0cf9-9207-404c-87a8-a1e0109af6cc6
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY764b0cf9-9207-404c-87a8-a1e0109af6cc6
313565valacyclovir (as valacyclovir HCl) 500 MG Oral TabletSY764b0cf9-9207-404c-87a8-a1e0109af6cc6
313564valacyclovir 1 GM Oral TabletSY764b0cf9-9207-404c-87a8-a1e0109af6cc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82009-041-908200900419090 TABLET, FILM COATED in 1 BOTTLE (82009-041-90) 2022-10-140000-00-00NoNoCurrent