Vilazodone Hydrochloride

Product NDC
16729-353
11-digit product format
167290353
Labeler code
16729
Product ID
16729-353_40aa8e57-b9a0-9e45-e063-6294a90ab03e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vilazodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA208209
Marketing category
ANDA
Marketing start
2022-06-04
Substance
VILAZODONE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 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
16729-353-01Vilazodone Hydrochloride100 in 1 BOTTLETABLET1006
16729-353-10Vilazodone Hydrochloride30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-353-10EA - Each16729-3534adf90ad-e8a6-412a-99ac-36be0ec0f5f612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-353VILAZODONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.]5Current NDC, Legacy NDC, 2 package rows20231214_f917f30d-f2a7-43eb-836f-53eaa2a31cb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086772vilazodone HCl 10 MG Oral TabletPSNf917f30d-f2a7-43eb-836f-53eaa2a31cb06
1086778vilazodone HCl 20 MG Oral TabletPSNf917f30d-f2a7-43eb-836f-53eaa2a31cb06
1086784vilazodone HCl 40 MG Oral TabletPSNf917f30d-f2a7-43eb-836f-53eaa2a31cb06
1086772vilazodone hydrochloride 10 MG Oral TabletSCDf917f30d-f2a7-43eb-836f-53eaa2a31cb06
1086778vilazodone hydrochloride 20 MG Oral TabletSCDf917f30d-f2a7-43eb-836f-53eaa2a31cb06
1086784vilazodone hydrochloride 40 MG Oral TabletSCDf917f30d-f2a7-43eb-836f-53eaa2a31cb06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-353-0116729035301100 in 1 BOTTLEHistorical
16729-353-101672903531030 TABLET in 1 BOTTLE (16729-353-10) 30 tablet2022-06-040000-00-00NoNoCurrent