vilazodone hydrochloride

Product NDC
82804-128
11-digit product format
828040128
Labeler code
82804
Product ID
82804-128_f68720fd-9122-4922-b472-733da8bd0a00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vilazodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208228
Marketing category
ANDA
Marketing start
2023-10-26
Substance
VILAZODONE HYDROCHLORIDE
Active strength
40 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VILAZODONE HYDROCHLORIDE40 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
f68720fd-9122-4922-b472-733da8bd0a00Available on FDA.report

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
82804-128-30vilazodone hydrochloride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-128-30EA - Each82804-128fba861e1-ceac-4600-9979-ec5620f635cc12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-128VILAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Current NDC, 1 package rows20240724_f68720fd-9122-4922-b472-733da8bd0a00.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
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
ndc (product): 82804-128
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
1086784vilazodone HCl 40 MG Oral TabletPSNf68720fd-9122-4922-b472-733da8bd0a001
1086784vilazodone hydrochloride 40 MG Oral TabletSCDf68720fd-9122-4922-b472-733da8bd0a001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-128-308280401283030 TABLET in 1 BOTTLE (82804-128-30) 30 tablet2024-07-19NoNoCurrent