vilazodone hydrochloride

Product NDC
68788-8735
11-digit product format
687888735
Labeler code
68788
Product ID
68788-8735_87fcca39-c5dc-4018-9701-c73bff8d42d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vilazodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208228
Marketing category
ANDA
Marketing start
2024-09-16
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
Rxcui1086778, 1086784

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
849a96e0-28d6-f8a5-3c99-ba4329994503Product name320211014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8735-3vilazodone hydrochloride30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8735-3EA - Each68788-87355014697b-9ebb-4671-9da1-c368ecfaa43012024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8735VILAZODONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 1 package rows20240918_061efdcc-40ea-4647-8cc8-01cd1ccca68b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086778vilazodone HCl 20 MG Oral TabletPSN061efdcc-40ea-4647-8cc8-01cd1ccca68b2
1086784vilazodone HCl 40 MG Oral TabletPSN061efdcc-40ea-4647-8cc8-01cd1ccca68b2
1086778vilazodone hydrochloride 20 MG Oral TabletSCD061efdcc-40ea-4647-8cc8-01cd1ccca68b2
1086784vilazodone hydrochloride 40 MG Oral TabletSCD061efdcc-40ea-4647-8cc8-01cd1ccca68b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8735-36878887350330 TABLET in 1 BOTTLE (68788-8735-3) 30 tablet2024-09-16NoNoHistorical