Vilazodone Hydrochloride

Product NDC
76282-544
11-digit product format
762820544
Labeler code
76282
Product ID
76282-544_da0f5799-ae08-4f50-b909-96c73adeeb31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vilazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA208200
Marketing category
ANDA
Marketing start
2022-12-01
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
76282-544-30Vilazodone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-544VILAZODONE HYDROCHLORIDE TABLET, FILM COATED VILAZODONE HYDROCHLORIDE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20241222_d1d8b51c-823b-4702-a726-a7530abd8957.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086772vilazodone HCl 10 MG Oral TabletPSNd1d8b51c-823b-4702-a726-a7530abd89573
1086778vilazodone HCl 20 MG Oral TabletPSNd1d8b51c-823b-4702-a726-a7530abd89573
1086784vilazodone HCl 40 MG Oral TabletPSNd1d8b51c-823b-4702-a726-a7530abd89573
1086772vilazodone hydrochloride 10 MG Oral TabletSCDd1d8b51c-823b-4702-a726-a7530abd89573
1086778vilazodone hydrochloride 20 MG Oral TabletSCDd1d8b51c-823b-4702-a726-a7530abd89573
1086784vilazodone hydrochloride 40 MG Oral TabletSCDd1d8b51c-823b-4702-a726-a7530abd89573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-544-307628205443030 TABLET, FILM COATED in 1 BOTTLE (76282-544-30) 2022-12-010000-00-00NoNoCurrent