vilazodone hydrochloride

Product NDC
68788-8734
11-digit product format
687888734
Labeler code
68788
Product ID
68788-8734_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
20 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
A208228-001VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-07
A208228-002VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-07
A208228-003VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208228-001AB
A208228-002AB
A208228-003AB

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 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-0784e616aacf4f…
2026-09-14 22:38:342026-08A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-0784e616aacf4f…
2026-08-18 06:07:402026-07A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208228-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2023-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208228-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2023-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208228-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2023-07-07301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208228-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208228-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208228-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A208228-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208228-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208228-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208228-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208228-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208228-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208228-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208228-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208228-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208228-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208228-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208228-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208228-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208228-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208228-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208228-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208228-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208228-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208228-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208228-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208228-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208228-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208228-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208228-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208228-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208228-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208228-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208228-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208228-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208228-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208228-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208228-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208228-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208228-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208228-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208228-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208228-001AB1301d65b070ca…

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 HYDROCHLORIDE20 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
061efdcc-40ea-4647-8cc8-01cd1ccca68bAvailable on FDA.report

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
68788-8734-3vilazodone hydrochloride30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8734-3EA - Each68788-8734b82da8ef-4422-42ee-a364-b6ef4110f1f212024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8734VILAZODONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 1 package rows20240918_061efdcc-40ea-4647-8cc8-01cd1ccca68b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
vilazodone hydrochlorideVILAZODONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.061efdcc-40ea-4647-8cc8-01cd1ccca68b2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208228
application number: ANDA208228
ndc (product): 68788-8734
vilazodone hydrochlorideVILAZODONE HYDROCHLORIDENorthstar Rx LLC701c8b84-13ae-4adb-af7a-304bf1f21e3b2024-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208228
application number: ANDA208228
vilazodone hydrochlorideVILAZODONE HYDROCHLORIDEProficient Rx LPf68720fd-9122-4922-b472-733da8bd0a002024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208228
application number: ANDA208228
vilazodone hydrochlorideVILAZODONE HYDROCHLORIDENovadoz Pharmaceuticals LLCc3e167cd-7f56-45eb-80df-a60fa1392e572023-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208228
application number: ANDA208228

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
68788-8734-36878887340330 TABLET in 1 BOTTLE (68788-8734-3) 30 tablet2024-09-16NoNoCurrent