VILAZODONE HYDROCHLORIDE

Product NDC
62332-232
11-digit product format
623320232
Labeler code
62332
Product ID
62332-232_d97cafa3-ede7-49c6-bba1-6414e6968cb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VILAZODONE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208202-001VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-10
A208202-002VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-10
A208202-003VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208202-001AB
A208202-002AB
A208202-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-1084e616aacf4f…
2026-09-14 22:38:342026-08A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-1084e616aacf4f…
2026-09-14 22:38:342026-08A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-1084e616aacf4f…
2026-08-18 06:07:402026-07A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208202-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2020-01-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208202-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2020-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208202-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2020-01-10301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208202-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208202-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208202-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A208202-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208202-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208202-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208202-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208202-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208202-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208202-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208202-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208202-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208202-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208202-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208202-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208202-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208202-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208202-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208202-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208202-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208202-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208202-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208202-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208202-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208202-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208202-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208202-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208202-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208202-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208202-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208202-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208202-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208202-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208202-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208202-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208202-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208202-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208202-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208202-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208202-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U8HTX2GK8JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086772Internal RxNorm lookup
1086778Internal RxNorm lookup
1086784Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b95b850-8bdf-4255-a691-783d1a94bd07Available on FDA.report

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
62332-232-30VILAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3011
62332-232-71VILAZODONE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED50011
62332-232-90VILAZODONE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9011
62332-232-91VILAZODONE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-232-30EA - Each62332-2322c1e935b-8a94-48aa-857d-b4355391f6c012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-232VILAZODONE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 4 package rows20240717_8b95b850-8bdf-4255-a691-783d1a94bd07.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDEAlembic Pharmaceuticals Inc.8b95b850-8bdf-4255-a691-783d1a94bd072024-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208202
application number: ANDA208202
ndc (product): 62332-232
VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDEAlembic Pharmaceuticals Limited0374fbb1-b0fb-4150-b1e7-92e2b0d32ecf2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208202
application number: ANDA208202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086772vilazodone HCl 10 MG Oral TabletPSN8b95b850-8bdf-4255-a691-783d1a94bd0711
1086778vilazodone HCl 20 MG Oral TabletPSN8b95b850-8bdf-4255-a691-783d1a94bd0711
1086784vilazodone HCl 40 MG Oral TabletPSN8b95b850-8bdf-4255-a691-783d1a94bd0711
1086772vilazodone hydrochloride 10 MG Oral TabletSCD8b95b850-8bdf-4255-a691-783d1a94bd0711
1086778vilazodone hydrochloride 20 MG Oral TabletSCD8b95b850-8bdf-4255-a691-783d1a94bd0711
1086784vilazodone hydrochloride 40 MG Oral TabletSCD8b95b850-8bdf-4255-a691-783d1a94bd0711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-232-306233202323030 TABLET, FILM COATED in 1 BOTTLE (62332-232-30) 2022-06-040000-00-00NoNoCurrent
62332-232-7162332023271500 TABLET, FILM COATED in 1 BOTTLE (62332-232-71) 2022-06-040000-00-00NoNoCurrent
62332-232-906233202329090 TABLET, FILM COATED in 1 BOTTLE (62332-232-90) 2022-06-040000-00-00NoNoCurrent
62332-232-91623320232911000 TABLET, FILM COATED in 1 BOTTLE (62332-232-91) 2022-06-040000-00-00NoNoCurrent