Home NDC 63629-8531 Ramelteon
Product NDC 63629-8531
11-digit product format 636298531
Labeler code 63629
Product ID 63629-8531_efc72bca-fc54-4a93-abb7-6c8621d8faf1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramelteon
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA213186
Marketing category ANDA
Marketing start 2020-10-01
Substance RAMELTEON
Active strength 8 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 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 A213186-001 RAMELTEON RAMELTEON 8MG TABLET / ORAL 2020-08-21
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 2026-02-19 14:30 UTC 2026-02 A213186-001 RAMELTEON 8MG TABLET / ORAL 2020-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213186-001 RAMELTEON 8MG TABLET / ORAL 2020-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213186-001 RAMELTEON 8MG TABLET / ORAL AB 2020-08-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213186-001 RAMELTEON 8MG TABLET / ORAL 2020-08-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ramelteon
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577348 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 63629-8531-1 Ramelteon 30 in 1 BOTTLE TABLET 30 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8531 RAMELTEON TABLET [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 1 package rows 20240420_af1db3bf-1c7c-441e-8497-7c35f45fb00e.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 · 4 matching rows.
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 63629-8531-1 63629853101 30 TABLET in 1 BOTTLE (63629-8531-1) 30 tablet 2020-10-01 0000-00-00 No No Current