vilazodone hydrochloride

Product NDC
60505-4372
11-digit product format
605054372
Labeler code
60505
Product ID
60505-4372_cf01e721-c246-593a-b0f8-20e03347b9a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vilazodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA208228
Marketing category
ANDA
Marketing start
2023-10-26
Substance
VILAZODONE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VILAZODONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU8HTX2GK8J
Rxcui1086772, 1086778, 1086784

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
849a96e0-28d6-f8a5-3c99-ba4329994503Product name320211014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4372-0vilazodone hydrochloride100 in 1 BLISTER PACKTABLET1006
60505-4372-3vilazodone hydrochloride30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4372VILAZODONE HYDROCHLORIDE TABLET [APOTEX CORP.]6Current NDC, 2 package rows20250214_a70fd858-cbef-7336-d7ce-c78499031644.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086772vilazodone HCl 10 MG Oral TabletPSNa70fd858-cbef-7336-d7ce-c784990316446
1086778vilazodone HCl 20 MG Oral TabletPSNa70fd858-cbef-7336-d7ce-c784990316446
1086784vilazodone HCl 40 MG Oral TabletPSNa70fd858-cbef-7336-d7ce-c784990316446
1086772vilazodone hydrochloride 10 MG Oral TabletSCDa70fd858-cbef-7336-d7ce-c784990316446
1086778vilazodone hydrochloride 20 MG Oral TabletSCDa70fd858-cbef-7336-d7ce-c784990316446
1086784vilazodone hydrochloride 40 MG Oral TabletSCDa70fd858-cbef-7336-d7ce-c784990316446

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4372-060505437200100 in 1 BLISTER PACKHistorical
60505-4372-36050543720330 TABLET in 1 BOTTLE (60505-4372-3) 30 tablet2023-10-26NoNoHistorical