Home Applications 021782 Application 021782
Type NDA
Sponsor TAKEDA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROZEREM RAMELTEON TABLET;ORAL 8MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021782-001 ROZEREM RAMELTEON 8MG TABLET / ORAL AB RLD, RS 2005-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021782-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021782-001 ROZEREM 8MG TABLET / ORAL AB RLD, RS 2005-07-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021782-001 6034239 2019-07-22 U-674 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021782-001 10098866 2021-11-16 U-2433 Drug product 2018-11-06 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021782-001 10098866 2021-11-16 U-2433 Drug product 2018-11-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021782-001 10098866 2021-11-16 U-2433 Drug product 2018-11-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021782-001 10098866 2021-11-16 U-2433 Drug product 2018-11-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021782-001 10098866 2021-11-16 U-2433 Drug product 2018-11-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021782-001 10098866 2021-11-16 U-2433 Drug product 2018-11-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021782-001 6034239 2019-07-22 U-674 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021782-001 10098866 2021-11-16 U-2433 Drug product 2018-11-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021782-001 6034239 2019-07-22 U-674 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021782-001 10098866 2021-11-16 U-2433 Drug product 2018-11-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021782-001 6034239 2019-07-22 U-674 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021782-001 10098866 2021-11-16 U-2433 Drug product 2018-11-06 ea99ee380514…
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 Rozerem RAMELTEON Takeda Pharmaceuticals America, Inc. 9de82310-70e8-47b9-b1fc-6c6848b99455 2026-04-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 021782 application number: NDA021782 ndc (product): 64764-805
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-183 Rozerem ramelteon Rebel Distributors Corp NDA Current 63629-3389 Rozerem ramelteon Bryant Ranch Prepack NDA Current 63629-3389 Rozerem ramelteon Bryant Ranch Prepack NDA Current 64764-805 Rozerem ramelteon Takeda Pharmaceuticals America, Inc. NDA Current 64764-805 Rozerem ramelteon Takeda Pharmaceuticals America, Inc. NDA Current 64764-805 Rozerem ramelteon Takeda Pharmaceuticals America, Inc. NDA Current 64764-805 Rozerem ramelteon Takeda Pharmaceuticals America, Inc. NDA Current 68151-4881 Rozerem ramelteon Carilion Materials Management NDA Current