Home NDC 64764-805 Rozerem
Product NDC 64764-805
11-digit product format 647640805
Labeler code 64764
Product ID 64764-805_2021e7fb-108a-4783-9a37-8bc05bf28b28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ramelteon
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA021782
Marketing category NDA
Marketing start 2005-07-22
Substance RAMELTEON
Active strength 8 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 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…
Additional Listing Data#
Finished product Yes
Brand name base Rozerem
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RAMELTEON 8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 901AS54I69 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577348 Internal RxNorm lookup 603162 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 64764-805-10 Rozerem 100 in 1 BOTTLE TABLET, FILM COATED 100 20 64764-805-22 Rozerem 6 in 1 TRAY TABLET, FILM COATED 6 20 64764-805-22 Rozerem 1 in 1 CARTON TABLET, FILM COATED 1 20 64764-805-30 Rozerem 30 in 1 BOTTLE TABLET, FILM COATED 30 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RAMELTEON ACTIVE INGREDIENT 901AS54I69 ROZEREM (RAMELTEON) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 RAMELTEON ACTIVE MOIETY 901AS54I69 ROZEREM (RAMELTEON) TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 ramelteon ACTIVE INGREDIENT 901AS54I69 ROZEREM (RAMELTEON) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 10 ramelteon ACTIVE MOIETY 901AS54I69 ROZEREM (RAMELTEON) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 10 ramelteon ACTIVE INGREDIENT 901AS54I69 ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 RAMELTEON ACTIVE INGREDIENT 901AS54I69 ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 RAMELTEON ACTIVE MOIETY 901AS54I69 ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 ramelteon ACTIVE MOIETY 901AS54I69 ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 copovidone INACTIVE INGREDIENT D9C330MD8B ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 COPOVIDONE INACTIVE INGREDIENT D9C330MD8B ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 polyethylene glycol 8000 INACTIVE INGREDIENT Q662QK8M3B ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 shellac INACTIVE INGREDIENT 46N107B71O ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 starch, corn INACTIVE INGREDIENT O8232NY3SJ ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ROZEREM (RAMELTEON) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64764-805 ROZEREM (RAMELTEON) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 17 Current NDC, Legacy NDC, 4 package rows 20230106_9de82310-70e8-47b9-b1fc-6c6848b99455.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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64764-805-10 64764080510 100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10) 2005-07-22 0000-00-00 No No Current 64764-805-22 64764080522 6 CARTON in 1 TRAY (64764-805-22) > 1 BLISTER PACK in 1 CARTON > 2 TABLET, FILM COATED in 1 BLISTER PACK 6 carton 2005-07-22 0000-00-00 No No Current 64764-805-30 64764080530 30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30) 2005-07-22 0000-00-00 No No Current