Home NDC 82804-128 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208228-001 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 A208228-002 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 A208228-003 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208228-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2023-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208228-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2023-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208228-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-07-07 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
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 Ingredient Strength VILAZODONE HYDROCHLORIDE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U8HTX2GK8J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086784 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82804-128-30 vilazodone hydrochloride 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-128 VILAZODONE HYDROCHLORIDE TABLET [PROFICIENT RX LP] 1 Current NDC, 1 package rows 20240724_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join vilazodone hydrochloride VILAZODONE HYDROCHLORIDE Preferred Pharmaceuticals Inc. 061efdcc-40ea-4647-8cc8-01cd1ccca68b 2025-10-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208228 application number: ANDA208228 vilazodone hydrochloride VILAZODONE HYDROCHLORIDE Northstar Rx LLC 701c8b84-13ae-4adb-af7a-304bf1f21e3b 2024-11-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208228 application number: ANDA208228 vilazodone hydrochloride VILAZODONE HYDROCHLORIDE Proficient Rx LP f68720fd-9122-4922-b472-733da8bd0a00 2024-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208228 application number: ANDA208228 ndc (product): 82804-128 vilazodone hydrochloride VILAZODONE HYDROCHLORIDE Novadoz Pharmaceuticals LLC c3e167cd-7f56-45eb-80df-a60fa1392e57 2023-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208228 application number: ANDA208228
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82804-128-30 82804012830 30 TABLET in 1 BOTTLE (82804-128-30) 30 tablet 2024-07-19 No No Current