Tasimelteon

Product NDC: 0480-4490
Requested package NDC: 0480-4490-00
11-digit product format: 004804490
Labeler code: 0480
Product ID: 0480-4490_84fb7983-5377-442b-b099-d6fbacb0f4ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tasimelteon
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Teva Pharmaceuticals, Inc.
Application: ANDA211601
Marketing category: ANDA
Marketing start: 2022-12-29
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0480-4490	0480-4490-00	UNFINISHED	Active or certified unfinished drug listing		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`

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
A211601-001	TASIMELTEON	TASIMELTEON	20MG	CAPSULE / ORAL	AB		2022-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211601-001	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.

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	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211601-001	TASIMELTEON	20MG	CAPSULE / ORAL	AB	2022-12-12	`a50c72e98297…`

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	A211601-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211601-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211601-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211601-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211601-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211601-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211601-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211601-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211601-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211601-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211601-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211601-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211601-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211601-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211601-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211601-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211601-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211601-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211601-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211601-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211601-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211601-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211601-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211601-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211601-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211601-001	AB	1	`a50c72e98297…`

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: Tasimelteon
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1490473	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
ce5a2fa3-ed54-422d-96c2-1821496eb32f	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0480-4490-56	Tasimelteon	30 in 1 BOTTLE	CAPSULE, GELATIN COATED	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0480-4490-56	EA - Each	0480-4490	ff709e9b-a1c5-4eda-b7a7-01c7b49b38c7	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0480-4490	TASIMELTEON CAPSULE, GELATIN COATED [TEVA PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20250205_ce5a2fa3-ed54-422d-96c2-1821496eb32f.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
Tasimelteon	TASIMELTEON	Teva Pharmaceuticals, Inc.	ce5a2fa3-ed54-422d-96c2-1821496eb32f	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211601 application number: ANDA211601 ndc (product): 0480-4490

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
1490473	tasimelteon 20 MG Oral Capsule	PSN	ce5a2fa3-ed54-422d-96c2-1821496eb32f	5
1490473	tasimelteon 20 MG Oral Capsule	SCD	ce5a2fa3-ed54-422d-96c2-1821496eb32f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
0480-4490-00	00480449000	19950 CAPSULE, GELATIN COATED in 1 BOX (0480-4490-00)	30-MAY-23	Current