Home NDC 60505-4665 Tasimelteon
Product NDC 60505-4665
11-digit product format 605054665
Labeler code 60505
Product ID 60505-4665_6920d3c7-5e2f-1303-d9dd-85d7c1dfba8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tasimelteon
Dosage form CAPSULE
Route ORAL
Labeler Apotex Corp.
Application ANDA211607
Marketing category ANDA
Marketing start 2024-01-05
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 A211607-001 TASIMELTEON TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211607-001 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 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211607-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2022-12-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A211607-001 PC 2023-06-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211607-001 PC 2023-06-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211607-001 PC 2023-06-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211607-001 PC 2023-06-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211607-001 PC 2023-06-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211607-001 PC 2023-06-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211607-001 PC 2023-06-27 3bdfa0b2c4d7…
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4665-3 Tasimelteon 30 in 1 BOTTLE CAPSULE 30 2 60505-4665-9 Tasimelteon 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4665 TASIMELTEON CAPSULE [APOTEX CORP.] 2 Current NDC, 2 package rows 20250411_46b09064-a675-92d5-24a7-dac0410f77ae.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-4665-3 60505466503 30 CAPSULE in 1 BOTTLE (60505-4665-3) 30 capsule 2024-01-05 No No Current 60505-4665-9 60505466509 90 CAPSULE in 1 BOTTLE (60505-4665-9) 90 capsule 2024-01-05 No No Current