Hetlioz

Product NDC: 43068-220
11-digit product format: 430680220
Labeler code: 43068
Product ID: 43068-220_8463c372-11ff-4caf-ad72-54d54a4a795d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tasimelteon
Dosage form: CAPSULE
Route: ORAL
Labeler: Vanda Pharmaceuticals Inc.
Application: NDA205677
Marketing category: NDA
Marketing start: 2014-04-04
Substance: TASIMELTEON
Active strength: 20 mg/1
Pharmacologic classes: Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205677-001	HETLIOZ	TASIMELTEON	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N205677-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 48 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205677-001	10149829	2033-01-25	U-2477		2018-12-27
N205677-001	10149829	2033-01-25	U-3006		2018-12-27
N205677-001	10449176	2033-01-25	U-2149		2019-11-20
N205677-001	10610510	2033-01-25	U-2805		2020-05-08
N205677-001	10610510	2033-01-25	U-3009		2020-05-08
N205677-001	10945988	2033-01-25	U-2149		2021-03-25
N205677-001	10980770	2033-01-25	U-3106		2021-04-15
N205677-001	10980770	2033-01-25	U-3107		2021-04-15
N205677-001	11285129	2033-01-25	U-3342		2022-04-15
N205677-001	11285129	2033-01-25	U-3343		2022-04-15
N205677-001	11633377	2033-01-25	U-2149		2023-04-27
N205677-001	11633377	2033-01-25	U-3003		2023-04-27
N205677-001	11826339	2033-01-25	U-3342		2024-04-04
N205677-001	11826339	2033-01-25	U-3343		2024-04-04
N205677-001	11833130	2033-01-25	U-2149		2024-01-03
N205677-001	11833130	2033-01-25	U-3003		2024-01-03
N205677-001	11850229	2033-01-25	U-3342		2024-01-03
N205677-001	11850229	2033-01-25	U-3343		2024-01-03
N205677-001	11918557	2033-01-25	U-3003		2024-04-04
N205677-001	11918557	2033-01-25	U-3865		2024-04-04
N205677-001	12201604	2033-01-25	U-3003		2025-02-18
N205677-001	12201604	2033-01-25	U-3865		2025-02-18
N205677-001	9060995	2033-01-25	U-1710		2015-06-26
N205677-001	9539234	2033-01-25	U-1934		2017-01-11
N205677-001	9539234	2033-01-25	U-3004		2017-01-11
N205677-001	9549913	2033-01-25	U-1486		2017-01-27
N205677-001	9855241	2033-01-25	U-2149		2018-01-18
N205677-001	RE46604	2033-01-25	U-2147		2017-11-30
N205677-001	11918556	2033-04-07	U-3342		2024-04-04
N205677-001	11918556	2033-04-07	U-3343		2024-04-04
N205677-001	9730910	2034-05-17	U-2085		2017-08-22
N205677-001	9730910	2034-05-17	U-3005		2017-08-22
N205677-001	10610511	2034-10-10	U-2615		2020-05-08
N205677-001	10610511	2034-10-10	U-3007		2020-05-08
N205677-001	11141400	2034-10-10	U-2615		2021-10-25
N205677-001	11141400	2034-10-10	U-3007		2021-10-25
N205677-001	11786502	2034-10-10	U-3007		2023-11-13
N205677-001	11786502	2034-10-10	U-3739		2023-11-13
N205677-001	10071977	2035-02-12		Drug substance, Drug product	2018-09-17
N205677-001	10829465	2035-02-12		Drug substance, Drug product	2020-11-17
N205677-001	11566011	2035-02-12		Drug substance, Drug product	2023-02-15
N205677-001	11760740	2035-02-12		Drug substance, Drug product	2023-10-13
N205677-001	12049457	2035-02-12		Drug substance, Drug product	2024-08-02
N205677-001	10376487	2035-07-27	U-2615		2019-09-11
N205677-001	10376487	2035-07-27	U-3007		2019-09-11
N205677-001	10179119	2035-08-29	U-3003		2020-12-21
N205677-001	11266622	2035-08-29	U-3003		2022-06-14
N205677-001	11759446	2041-02-21	U-3003		2023-10-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205677-001	ODE-330	2027-12-01

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 · 43 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	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL	AB	RLD, RS	2014-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205677-001	HETLIOZ	20MG	CAPSULE / ORAL		RLD, RS	2014-01-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N205677-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205677-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205677-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205677-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205677-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205677-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205677-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205677-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205677-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205677-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205677-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205677-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205677-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205677-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205677-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205677-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205677-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205677-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205677-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205677-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205677-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205677-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205677-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205677-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205677-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205677-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 37 · 1,460 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205677-001	10149829	2033-01-25	U-2477		2018-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10149829	2033-01-25	U-3006		2018-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10449176	2033-01-25	U-2149		2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10610510	2033-01-25	U-3009		2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10610510	2033-01-25	U-2805		2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10945988	2033-01-25	U-2149		2021-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10980770	2033-01-25	U-3106		2021-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10980770	2033-01-25	U-3107		2021-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11285129	2033-01-25	U-3342		2022-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11285129	2033-01-25	U-3343		2022-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11633377	2033-01-25	U-2149		2023-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11633377	2033-01-25	U-3003		2023-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11826339	2033-01-25	U-3342		2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11826339	2033-01-25	U-3343		2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11833130	2033-01-25	U-2149		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11833130	2033-01-25	U-3003		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11850229	2033-01-25	U-3342		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11850229	2033-01-25	U-3343		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11918557	2033-01-25	U-3003		2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11918557	2033-01-25	U-3865		2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	12201604	2033-01-25	U-3003		2025-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	12201604	2033-01-25	U-3865		2025-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	9060995	2033-01-25	U-1710		2015-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	9539234	2033-01-25	U-1934		2017-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	9539234	2033-01-25	U-3004		2017-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	9549913	2033-01-25	U-1486		2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	9855241	2033-01-25	U-2149		2018-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	RE46604	2033-01-25	U-2147		2017-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11918556	2033-04-07	U-3342		2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11918556	2033-04-07	U-3343		2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	9730910	2034-05-17	U-2085		2017-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	9730910	2034-05-17	U-3005		2017-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10610511	2034-10-10	U-3007		2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10610511	2034-10-10	U-2615		2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11141400	2034-10-10	U-2615		2021-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11141400	2034-10-10	U-3007		2021-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11786502	2034-10-10	U-3007		2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	11786502	2034-10-10	U-3739		2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10071977	2035-02-12		Drug substance, Drug product	2018-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205677-001	10829465	2035-02-12		Drug substance, Drug product	2020-11-17	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N205677-001	ODE-330	2027-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205677-001	ODE-330	2027-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205677-001	ODE-330	2027-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205677-001	ODE-330	2027-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205677-001	ODE-330	2027-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205677-001	ODE-330	2027-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205677-001	ODE-330	2027-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205677-001	ODE-330	2027-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205677-001	ODE-330	2027-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205677-001	ODE-330	2027-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205677-001	ODE-330	2027-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205677-001	ODE-330	2027-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205677-001	ODE-330	2027-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205677-001	ODE-330	2027-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205677-001	ODE-330	2027-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205677-001	ODE-330	2027-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205677-001	I-850	2023-12-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205677-001	ODE-330	2027-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205677-001	I-850	2023-12-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205677-001	ODE-330	2027-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205677-001	I-850	2023-12-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205677-001	ODE-330	2027-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205677-001	NCE	2019-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205677-001	ODE-59	2021-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205677-001	I-850	2023-12-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205677-001	ODE-330	2027-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205677-001	ODE-59	2021-01-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205677-001	I-850	2023-12-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205677-001	ODE-330	2027-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205677-001	ODE-59	2021-01-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205677-001	I-850	2023-12-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205677-001	ODE-330	2027-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205677-001	ODE-59	2021-01-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205677-001	I-850	2023-12-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205677-001	ODE-59	2021-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205677-001	ODE-59	2021-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205677-001	NCE	2019-01-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205677-001	ODE-59	2021-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205677-001	NCE	2019-01-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205677-001	ODE-59	2021-01-31	`b00525d2431f…`

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: Hetlioz
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TASIMELTEON	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SHS4PU80D9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1490473	Internal RxNorm lookup
1491624	Internal RxNorm lookup
2468312	Internal RxNorm lookup
2468316	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
ca4a9b63-708e-49e9-8f9b-010625443b90	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b0ceaaa0-f09f-4b6b-aa19-c4134ebad977	Product name	3	20240205

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-08-14	These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ ® (tasimelteon) capsules, for oral use HETLIOZ LQ ™ (tasimelteon) oral suspension Initial U.S. Approval: 2014
2020-08-14	These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ ® (tasimelteon) capsules, for oral use HETLIOZ LQ ® (tasimelteon) oral suspension Initial U.S. Approval: 2014
2020-07-22	These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ ® (tasimelteon) capsules, for oral use HETLIOZ LQ ™ (tasimelteon) oral suspension Initial U.S. Approval: 2014
2020-07-22	These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ ® (tasimelteon) capsules, for oral use HETLIOZ LQ ® (tasimelteon) oral suspension Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43068-220-01	Hetlioz	30 in 1 BOTTLE	CAPSULE	30		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43068-220-01	EA - Each	43068-220	52934588-21be-43bc-8c93-2b087ff492c9	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TASIMELTEON	ACTIVE INGREDIENT	SHS4PU80D9	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
TASIMELTEON	ACTIVE MOIETY	SHS4PU80D9	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43068-220	HETLIOZ (TASIMELTEON) CAPSULE HETLIOZ LQ (TASIMELTEON) SUSPENSION [VANDA PHARMACEUTICALS INC.]	13	Current NDC, Legacy NDC, 1 package rows	20221223_ca4a9b63-708e-49e9-8f9b-010625443b90.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
Hetlioz	TASIMELTEON	Vanda Pharmaceuticals Inc.	ca4a9b63-708e-49e9-8f9b-010625443b90	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205677 application number: NDA205677 ndc (product): 43068-220

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SHS4PU80D9	TASIMELTEON	609799-22-6	TASIMELTEON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1491624	Hetlioz 20 MG Oral Capsule	PSN	ca4a9b63-708e-49e9-8f9b-010625443b90	13
2468316	Hetlioz LQ 4 MG/mL Oral Suspension	PSN	ca4a9b63-708e-49e9-8f9b-010625443b90	13
1490473	tasimelteon 20 MG Oral Capsule	PSN	ca4a9b63-708e-49e9-8f9b-010625443b90	13
2468312	tasimelteon 4 MG/mL Oral Suspension	PSN	ca4a9b63-708e-49e9-8f9b-010625443b90	13
1491624	tasimelteon 20 MG Oral Capsule [Hetlioz]	SBD	ca4a9b63-708e-49e9-8f9b-010625443b90	13
2468316	tasimelteon 4 MG/ML Oral Suspension [Hetlioz]	SBD	ca4a9b63-708e-49e9-8f9b-010625443b90	13
1490473	tasimelteon 20 MG Oral Capsule	SCD	ca4a9b63-708e-49e9-8f9b-010625443b90	13
2468312	tasimelteon 4 MG/ML Oral Suspension	SCD	ca4a9b63-708e-49e9-8f9b-010625443b90	13
1491624	Hetlioz 20 MG Oral Capsule	SY	ca4a9b63-708e-49e9-8f9b-010625443b90	13
2468316	Hetlioz 4 MG/ML Oral Suspension	SY	ca4a9b63-708e-49e9-8f9b-010625443b90	13
2468316	Hetlioz LQ 4 MG/ML Oral Suspension	SY	ca4a9b63-708e-49e9-8f9b-010625443b90	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43068-220-01	43068022001	30 CAPSULE in 1 BOTTLE (43068-220-01)	30 capsule	2014-04-04	0000-00-00	No	No	Current