FDA.reportPublic FDA data

Valacyclovir

Product NDC
50090-7270
11-digit product format
500907270
Labeler code
50090
Product ID
50090-7270_50117a81-fa76-4abc-bb77-1d30f2274a20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209553
Marketing category
ANDA
Marketing start
2023-02-14
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1000 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valacyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALACYCLOVIR HYDROCHLORIDE1000 mg/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
50090-7270-0Valacyclovir15 in 1 BOTTLETABLET151
50090-7270-1Valacyclovir21 in 1 BOTTLETABLET211
50090-7270-2Valacyclovir30 in 1 BOTTLETABLET301
50090-7270-3Valacyclovir90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7270-0EA - Each50090-72705fa473c8-2b1c-449e-b9e5-4e67931c10bc12024-11-05
50090-7270-1EA - Each50090-72700bf37efc-926d-4c3b-8951-b6089ca8e34612024-11-05
50090-7270-2EA - Each50090-72704ca46d5a-cb80-46ad-8228-24c39d17524a12024-11-05
50090-7270-3EA - Each50090-727007d478e7-714d-4ebf-b79a-04df9a45bd5212024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7270VALACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20241012_6719e877-cff4-4be8-a352-8df0afa4f74c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313564valACYclovir 1 GM Oral TabletPSN6719e877-cff4-4be8-a352-8df0afa4f74c1
313564valacyclovir 1000 MG Oral TabletSCD6719e877-cff4-4be8-a352-8df0afa4f74c1
313564valacyclovir (as valacyclovir HCl) 1 GM Oral TabletSY6719e877-cff4-4be8-a352-8df0afa4f74c1
313564valacyclovir 1 GM Oral TabletSY6719e877-cff4-4be8-a352-8df0afa4f74c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7270-05009072700015 TABLET in 1 BOTTLE (50090-7270-0) 15 tablet2024-10-08NoNoCurrent
50090-7270-15009072700121 TABLET in 1 BOTTLE (50090-7270-1) 21 tablet2024-10-08NoNoCurrent
50090-7270-25009072700230 TABLET in 1 BOTTLE (50090-7270-2) 30 tablet2024-10-08NoNoCurrent
50090-7270-35009072700390 TABLET in 1 BOTTLE (50090-7270-3) 90 tablet2024-10-08NoNoCurrent