Home NDC 72189-484 Ramelteon
Product NDC 72189-484
11-digit product format 721890484
Labeler code 72189
Product ID 72189-484_2c4e2815-f2db-5672-e063-6294a90a5c3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramelteon
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Direct_Rx
Application ANDA213815
Marketing category ANDA
Marketing start 2023-06-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-484-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-484-30 0efc9e666f02…f202fb6c5f17…
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 A213815-001 RAMELTEON RAMELTEON 8MG TABLET / ORAL AB 2020-10-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213815-001 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 2026-02-19 14:30 UTC 2026-02 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213815-001 RAMELTEON 8MG TABLET / ORAL AB 2020-10-26 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 72189-484-30 Ramelteon 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-484 RAMELTEON TABLET, FILM COATED [DIRECT_RX] 2 Current NDC, 1 package rows 20250123_fd169dd8-70a0-b6b4-e053-6394a90a3a6f.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72189-484-30 72189048430 30 TABLET, FILM COATED in 1 BOTTLE (72189-484-30) 2023-06-01 No No Current