vilazodone hydrochloride

Product NDC: 72205-261
11-digit product format: 722050261
Labeler code: 72205
Product ID: 72205-261_c3e167cd-7f56-45eb-80df-a60fa1392e57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vilazodone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Novadoz Pharmaceuticals LLC
Application: ANDA208228
Marketing category: ANDA
Marketing start: 2023-07-07
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	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.

Application-product, TE code table
Application-product	TE code
A208228-001	AB
A208228-002	AB
A208228-003	AB

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208228-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208228-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208228-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208228-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208228-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208228-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208228-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208228-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208228-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208228-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208228-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208228-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208228-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208228-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208228-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208228-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208228-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208228-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208228-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208228-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208228-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208228-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208228-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208228-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208228-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208228-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208228-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208228-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208228-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208228-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208228-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208228-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208228-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208228-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208228-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208228-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208228-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208228-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208228-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208228-001	AB	1	`301d65b070ca…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c3e167cd-7f56-45eb-80df-a60fa1392e57	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
849a96e0-28d6-f8a5-3c99-ba4329994503	Product name	3	20211014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72205-261-30	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
72205-261	VILAZODONE HYDROCHLORIDE TABLET [NOVADOZ PHARMACEUTICALS LLC]	1	Current NDC, 1 package rows	20230930_c3e167cd-7f56-45eb-80df-a60fa1392e57.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
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 ndc (product): 72205-261

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U8HTX2GK8J	VILAZODONE HYDROCHLORIDE	163521-08-2	VILAZODONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1086778	vilazodone HCl 20 MG Oral Tablet	PSN	061efdcc-40ea-4647-8cc8-01cd1ccca68b	2
1086784	vilazodone HCl 40 MG Oral Tablet	PSN	061efdcc-40ea-4647-8cc8-01cd1ccca68b	2
1086778	vilazodone hydrochloride 20 MG Oral Tablet	SCD	061efdcc-40ea-4647-8cc8-01cd1ccca68b	2
1086784	vilazodone hydrochloride 40 MG Oral Tablet	SCD	061efdcc-40ea-4647-8cc8-01cd1ccca68b	2
1086772	vilazodone HCl 10 MG Oral Tablet	PSN	c3e167cd-7f56-45eb-80df-a60fa1392e57	1
1086778	vilazodone HCl 20 MG Oral Tablet	PSN	c3e167cd-7f56-45eb-80df-a60fa1392e57	1
1086784	vilazodone HCl 40 MG Oral Tablet	PSN	c3e167cd-7f56-45eb-80df-a60fa1392e57	1
1086772	vilazodone hydrochloride 10 MG Oral Tablet	SCD	c3e167cd-7f56-45eb-80df-a60fa1392e57	1
1086778	vilazodone hydrochloride 20 MG Oral Tablet	SCD	c3e167cd-7f56-45eb-80df-a60fa1392e57	1
1086784	vilazodone hydrochloride 40 MG Oral Tablet	SCD	c3e167cd-7f56-45eb-80df-a60fa1392e57	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72205-261-30	72205026130	30 TABLET in 1 BOTTLE (72205-261-30)	30 tablet	2023-07-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
vilazodone hydrochloride	Preferred Pharmaceuticals Inc.	2025-10-07	HUMAN PRESCRIPTION DRUG LABEL	2
vilazodone hydrochloride	Novadoz Pharmaceuticals LLC \| MSN LABORATORIES PRIVATE LIMITED	2023-06-30	Human Prescription Drug Label	1