Home NDC 69238-2548 Tasimelteon
Product NDC 69238-2548
11-digit product format 692382548
Labeler code 69238
Product ID 69238-2548_071804f4-9647-4a4d-a394-55b9e976dc9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tasimelteon
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA211654
Marketing category ANDA
Marketing start 2023-02-24
Substance TASIMELTEON
Active strength 20 mg/1
Pharmacologic classes Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211654-001 TASIMELTEON TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211654-001 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 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211654-001 TASIMELTEON 20MG CAPSULE / ORAL AB 2023-01-12 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 2026-12-31 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 69238-2548-3 Tasimelteon 30 in 1 BOTTLE CAPSULE 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-2548 TASIMELTEON CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] 7 Current NDC, 1 package rows 20230331_99cb1928-e57d-4d04-87a1-38108780598a.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 Units Marketing start Sample Exclude flag Status 69238-2548-3 69238254803 30 CAPSULE in 1 BOTTLE (69238-2548-3) 30 capsule 2023-02-24 No No Current