Home NDC 60505-4772 vilazodone
Product NDC 60505-4772
11-digit product format 605054772
Labeler code 60505
Product ID 60505-4772_27cec315-2f77-4048-861e-31e24701b60c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vilazodone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Apotex Corp
Application NDA022567
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-06-04
Marketing end 0000-00-00
Substance VILAZODONE HYDROCHLORIDE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 N022567-001 VIIBRYD VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB RLD, RS 2011-01-21 N022567-002 VIIBRYD VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB RLD 2011-01-21 N022567-003 VIIBRYD VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB RLD 2011-01-21
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 4 · 129 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 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022567-002 VIIBRYD 20MG TABLET / ORAL AB RLD 2011-01-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022567-003 VIIBRYD 40MG TABLET / ORAL AB RLD 2011-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022567-001 VIIBRYD 10MG TABLET / ORAL AB RLD, RS 2011-01-21 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book patent history# Patent history page 1 of 10 · 396 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-001 7834020 2022-06-05 U-839 Drug substance, Drug product 2011-01-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-001 8193195 2022-06-05 U-839 2012-06-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-001 8236804 2022-06-05 U-839 2012-08-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-001 8673921 2022-06-05 Drug substance, Drug product 2014-03-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-001 7834020*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-001 8193195*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-001 8236804*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-001 8673921*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-002 7834020 2022-06-05 U-839 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-002 8193195 2022-06-05 U-839 2012-06-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-002 8236804 2022-06-05 U-839 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-002 8673921 2022-06-05 Drug substance, Drug product 2014-03-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-002 7834020*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-002 8193195*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-002 8236804*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-002 8673921*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-003 7834020 2022-06-05 U-839 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-003 8193195 2022-06-05 U-839 2012-06-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-003 8236804 2022-06-05 U-839 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-003 8673921 2022-06-05 Drug substance, Drug product 2014-03-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-003 7834020*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-003 8193195*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-003 8236804*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022567-003 8673921*PED 2022-12-05 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022567-001 7834020 2022-06-05 U-839 Drug substance, Drug product 2011-01-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-001 8193195 2022-06-05 U-839 2012-06-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-001 8236804 2022-06-05 U-839 2012-08-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-001 8673921 2022-06-05 Drug substance, Drug product 2014-03-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-001 7834020*PED 2022-12-05 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-001 8193195*PED 2022-12-05 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-001 8236804*PED 2022-12-05 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-001 8673921*PED 2022-12-05 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-002 7834020 2022-06-05 U-839 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-002 8193195 2022-06-05 U-839 2012-06-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-002 8236804 2022-06-05 U-839 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-002 8673921 2022-06-05 Drug substance, Drug product 2014-03-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-002 7834020*PED 2022-12-05 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-002 8193195*PED 2022-12-05 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-002 8236804*PED 2022-12-05 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022567-002 8673921*PED 2022-12-05 Pediatric extension 5d02ea3f76ae…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 120 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4772 VILAZODONE (VILAZODONE HYDROCHLORIDE) TABLET VILAZODONE (VILAZODONE HYDROCHLORIDE) TABLET [APOTEX CORP] 4 Legacy NDC 20241213_fad37b72-1ebe-4a71-835d-b0c1e4b90011.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VIIBRYD VILAZODONE HYDROCHLORIDE Allergan, Inc. 4c55ccfb-c4cf-11df-851a-0800200c9a66 2023-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022567 application number: NDA022567
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-4772-3 60505477203 30 TABLET in 1 BOTTLE (60505-4772-3) 30 tablet 2022-06-04 0000-00-00 No No Current