FDA.reportPublic FDA data

Vilazodone Hydrochloride

Product NDC
0480-2043
11-digit product format
004802043
Labeler code
0480
Product ID
0480-2043_5e283aac-a23f-4dd5-870e-19ca577b9000
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vilazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA208212
Marketing category
ANDA
Marketing start
2022-06-06
Substance
VILAZODONE HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU8HTX2GK8J
Rxcui1086772, 1086778, 1086784

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
849a96e0-28d6-f8a5-3c99-ba4329994503Product name320211014
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-2043-56Vilazodone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-2043-56EA - Each0480-2043a7d341f3-207e-40d5-bf9d-c4e2bb7ba85f12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-2043VILAZODONE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20250511_3a4745a0-de23-4b40-923e-0d7dfe6b8634.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086772vilazodone HCl 10 MG Oral TabletPSN3a4745a0-de23-4b40-923e-0d7dfe6b86344
1086778vilazodone HCl 20 MG Oral TabletPSN3a4745a0-de23-4b40-923e-0d7dfe6b86344
1086784vilazodone HCl 40 MG Oral TabletPSN3a4745a0-de23-4b40-923e-0d7dfe6b86344
1086772vilazodone hydrochloride 10 MG Oral TabletSCD3a4745a0-de23-4b40-923e-0d7dfe6b86344
1086778vilazodone hydrochloride 20 MG Oral TabletSCD3a4745a0-de23-4b40-923e-0d7dfe6b86344
1086784vilazodone hydrochloride 40 MG Oral TabletSCD3a4745a0-de23-4b40-923e-0d7dfe6b86344
1086772vilazodone HCl 10 MG Oral TabletPSN3b8ca479-72e9-2431-e063-6394a90af7ff1
1086778vilazodone HCl 20 MG Oral TabletPSN3b8ca479-72e9-2431-e063-6394a90af7ff1
1086784vilazodone HCl 40 MG Oral TabletPSN3b8ca479-72e9-2431-e063-6394a90af7ff1
1086772vilazodone hydrochloride 10 MG Oral TabletSCD3b8ca479-72e9-2431-e063-6394a90af7ff1
1086778vilazodone hydrochloride 20 MG Oral TabletSCD3b8ca479-72e9-2431-e063-6394a90af7ff1
1086784vilazodone hydrochloride 40 MG Oral TabletSCD3b8ca479-72e9-2431-e063-6394a90af7ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0480-2043-560048020435630 TABLET, FILM COATED in 1 BOTTLE (0480-2043-56) 2022-06-060000-00-00NoNoCurrent