Vilazodone Hydrochloride

Product NDC
51407-917
11-digit product format
514070917
Labeler code
51407
Product ID
51407-917_3b8c8c08-ce7c-b237-e063-6294a90aeb14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vilazodone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA208212
Marketing category
ANDA
Marketing start
2019-09-30
Substance
VILAZODONE HYDROCHLORIDE
Active strength
40 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
A208212-001VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-30
A208212-002VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-30
A208212-003VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208212-001AB
A208212-002AB
A208212-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-3084e616aacf4f…
2026-09-14 22:38:342026-08A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-3084e616aacf4f…
2026-08-18 06:07:402026-07A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208212-002VILAZODONE HYDROCHLORIDE20MGTABLET / ORALAB2019-09-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208212-003VILAZODONE HYDROCHLORIDE40MGTABLET / ORALAB2019-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208212-001VILAZODONE HYDROCHLORIDE10MGTABLET / ORALAB2019-09-30301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208212-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208212-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208212-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A208212-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208212-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208212-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208212-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208212-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208212-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208212-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208212-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208212-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208212-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208212-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208212-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208212-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208212-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208212-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208212-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208212-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208212-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208212-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208212-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208212-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208212-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208212-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208212-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208212-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208212-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208212-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208212-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208212-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208212-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208212-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208212-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208212-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208212-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208212-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208212-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208212-001AB1301d65b070ca…

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 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 · 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
3b8ca479-72e9-2431-e063-6394a90af7ffAvailable 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
51407-917-30Vilazodone Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-917-30EA - Each51407-917e2936e76-de09-475c-9400-d066c9b7bd9812025-09-12

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 HYDROCHLORIDEGolden State Medical Supply, Inc.3b8ca479-72e9-2431-e063-6394a90af7ff2025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208212
application number: ANDA208212
ndc (product): 51407-917
Vilazodone HydrochlorideVILAZODONE HYDROCHLORIDETeva Pharmaceuticals, Inc.3a4745a0-de23-4b40-923e-0d7dfe6b86342024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208212
application number: ANDA208212

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086772vilazodone HCl 10 MG Oral TabletPSN3b8ca479-72e9-2431-e063-6394a90af7ff1
1086778vilazodone HCl 20 MG Oral TabletPSN3b8ca479-72e9-2431-e063-6394a90af7ff1
1086784vilazodone HCl 40 MG Oral TabletPSN3b8ca479-72e9-2431-e063-6394a90af7ff1
1086772vilazodone hydrochloride 10 MG Oral TabletSCD3b8ca479-72e9-2431-e063-6394a90af7ff1
1086778vilazodone hydrochloride 20 MG Oral TabletSCD3b8ca479-72e9-2431-e063-6394a90af7ff1
1086784vilazodone hydrochloride 40 MG Oral TabletSCD3b8ca479-72e9-2431-e063-6394a90af7ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-917-305140709173030 TABLET, FILM COATED in 1 BOTTLE (51407-917-30) 2025-05-27NoNoCurrent