FDA.reportPublic FDA data

VILAZODONE HYDROCHLORIDE

Product NDC
46708-232
11-digit product format
467080232
Labeler code
46708
Product ID
46708-232_900c5751-06b2-49b5-86a0-275d75eef7f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VILAZODONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA208202
Marketing category
ANDA
Marketing start
2022-06-04
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
46708-232-30VILAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
46708-232-71VILAZODONE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5002
46708-232-90VILAZODONE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED902
46708-232-91VILAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-232VILAZODONE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, 4 package rows20230202_0374fbb1-b0fb-4150-b1e7-92e2b0d32ecf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086772vilazodone HCl 10 MG Oral TabletPSN0374fbb1-b0fb-4150-b1e7-92e2b0d32ecf2
1086778vilazodone HCl 20 MG Oral TabletPSN0374fbb1-b0fb-4150-b1e7-92e2b0d32ecf2
1086784vilazodone HCl 40 MG Oral TabletPSN0374fbb1-b0fb-4150-b1e7-92e2b0d32ecf2
1086772vilazodone hydrochloride 10 MG Oral TabletSCD0374fbb1-b0fb-4150-b1e7-92e2b0d32ecf2
1086778vilazodone hydrochloride 20 MG Oral TabletSCD0374fbb1-b0fb-4150-b1e7-92e2b0d32ecf2
1086784vilazodone hydrochloride 40 MG Oral TabletSCD0374fbb1-b0fb-4150-b1e7-92e2b0d32ecf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-232-304670802323030 TABLET, FILM COATED in 1 BOTTLE (46708-232-30) 2022-06-04NoNoCurrent
46708-232-7146708023271500 TABLET, FILM COATED in 1 BOTTLE (46708-232-71) 2022-06-04NoNoCurrent
46708-232-904670802329090 TABLET, FILM COATED in 1 BOTTLE (46708-232-90) 2022-06-04NoNoCurrent
46708-232-91467080232911000 TABLET, FILM COATED in 1 BOTTLE (46708-232-91) 2022-06-04NoNoCurrent