Home NDC 0480-4490 Tasimelteon
Product NDC 0480-4490
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 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0480-4490 UNFINISHED Active or certified unfinished drug listing 2026-10-05 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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0480-4490-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0480-4490-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0480-4490-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0480-4490-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0480-4490-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0480-4490-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0480-4490-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0480-4490-00 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0480-4490-00 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0480-4490-00 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0480-4490-00 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0480-4490-00 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0480-4490-00 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0480-4490-00 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 RLD / RS 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# 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.
DailyMed Product Concepts# 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 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.
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 0480-4490-00 00480449000 19950 CAPSULE, GELATIN COATED in 1 BOX (0480-4490-00) 30-MAY-23 Current 0480-4490-56 00480449056 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4490-56) 2022-12-29 0000-00-00 No No Current