Home NDC 69097-982 Vilazodone hydrochloride
Product NDC 69097-982
11-digit product format 690970982
Labeler code 69097
Product ID 69097-982_e16f2d8b-a5ec-498f-97c4-d1c9d897140f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vilazodone hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cipla USA Inc.
Application ANDA208200
Marketing category ANDA
Marketing start 2023-01-23
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208200-001 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 A208200-002 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 A208200-003 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06
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 3 · 98 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 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208200-002 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2021-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208200-003 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208200-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2021-04-07 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 98 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 2026-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086772 Internal RxNorm lookup 1086778 Internal RxNorm lookup 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 69097-982-02 Vilazodone hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-982 VILAZODONE HYDROCHLORIDE TABLET, FILM COATED VILAZODONE HYDROCHLORIDE TABLET, FILM COATED [CIPLA USA INC.] 2 Current NDC, 1 package rows 20241222_658c4bc1-4128-4e0e-8852-b5f68880e8d7.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69097-982-02 69097098202 30 TABLET, FILM COATED in 1 BOTTLE (69097-982-02) 2023-01-23 No No Current