Home NDC 0480-2044 Vilazodone Hydrochloride
Product NDC 0480-2044
11-digit product format 004802044
Labeler code 0480
Product ID 0480-2044_5e283aac-a23f-4dd5-870e-19ca577b9000
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vilazodone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA208212
Marketing category ANDA
Marketing start 2022-06-06
Substance VILAZODONE HYDROCHLORIDE
Active strength 20 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 A208212-001 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 A208212-002 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 A208212-003 VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30
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 · 123 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 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208212-002 VILAZODONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208212-003 VILAZODONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2019-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208212-001 VILAZODONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-09-30 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 99 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 20 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 0480-2044-56 Vilazodone Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-2044 VILAZODONE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20250511_3a4745a0-de23-4b40-923e-0d7dfe6b8634.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 Marketing end Sample Exclude flag Status 0480-2044-56 00480204456 30 TABLET, FILM COATED in 1 BOTTLE (0480-2044-56) 2022-06-06 0000-00-00 No No Current