Vilazodone hydrochloride

Product NDC
69097-981
11-digit product format
690970981
Labeler code
69097
Product ID
69097-981_e16f2d8b-a5ec-498f-97c4-d1c9d897140f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vilazodone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA208200
Marketing category
ANDA
Marketing start
2023-01-23
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
69097-981-02Vilazodone hydrochloride30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-981-02EA - Each69097-981d97c579a-1e3e-46c2-9895-70454d5e869812023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-981VILAZODONE HYDROCHLORIDE TABLET, FILM COATED VILAZODONE HYDROCHLORIDE TABLET, FILM COATED [CIPLA USA INC.]2Current NDC, 1 package rows20241222_658c4bc1-4128-4e0e-8852-b5f68880e8d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086772vilazodone HCl 10 MG Oral TabletPSN658c4bc1-4128-4e0e-8852-b5f68880e8d72
1086778vilazodone HCl 20 MG Oral TabletPSN658c4bc1-4128-4e0e-8852-b5f68880e8d72
1086784vilazodone HCl 40 MG Oral TabletPSN658c4bc1-4128-4e0e-8852-b5f68880e8d72
1086772vilazodone hydrochloride 10 MG Oral TabletSCD658c4bc1-4128-4e0e-8852-b5f68880e8d72
1086778vilazodone hydrochloride 20 MG Oral TabletSCD658c4bc1-4128-4e0e-8852-b5f68880e8d72
1086784vilazodone hydrochloride 40 MG Oral TabletSCD658c4bc1-4128-4e0e-8852-b5f68880e8d72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69097-981-026909709810230 TABLET, FILM COATED in 1 BOTTLE (69097-981-02) 2023-01-23NoNoHistorical