Home NDC 51407-523 Ramelteon
Product NDC 51407-523
11-digit product format 514070523
Labeler code 51407
Product ID 51407-523_2294061c-8ed1-8b41-e063-6394a90ada58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramelteon
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA216209
Marketing category ANDA
Marketing start 2022-11-25
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 A216209-001 RAMELTEON RAMELTEON 8MG TABLET / ORAL AB 2022-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216209-001 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 A216209-001 RAMELTEON 8MG TABLET / ORAL BX 2022-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216209-001 RAMELTEON 8MG TABLET / ORAL BX 2022-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216209-001 RAMELTEON 8MG TABLET / ORAL BX 2022-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216209-001 RAMELTEON 8MG TABLET / ORAL AB 2022-11-25 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 51407-523-01 Ramelteon 100 in 1 BOTTLE TABLET, FILM COATED 100 1 51407-523-30 Ramelteon 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-523 RAMELTEON TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Current NDC, 2 package rows 20240922_229403c5-de9c-dc61-e063-6394a90a2a70.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 · 2 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 51407-523-01 51407052301 100 TABLET, FILM COATED in 1 BOTTLE (51407-523-01) 2024-08-29 No No Current 51407-523-30 51407052330 30 TABLET, FILM COATED in 1 BOTTLE (51407-523-30) 2024-08-29 No No Current