Home NDC 59651-505 RAMELTEON
Product NDC 59651-505
11-digit product format 596510505
Labeler code 59651
Product ID 59651-505_ce8a4cd3-6dd1-48aa-a01b-cf08bda57ebb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RAMELTEON
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA215972
Marketing category ANDA
Marketing start 2023-07-10
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 A215972-001 RAMELTEON RAMELTEON 8MG TABLET / ORAL AB 2023-07-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215972-001 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 A215972-001 RAMELTEON 8MG TABLET / ORAL BX 2023-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215972-001 RAMELTEON 8MG TABLET / ORAL BX 2023-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215972-001 RAMELTEON 8MG TABLET / ORAL BX 2023-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215972-001 RAMELTEON 8MG TABLET / ORAL AB 2023-07-10 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 59651-505-01 RAMELTEON 100 in 1 BOTTLE TABLET, FILM COATED 100 3 59651-505-30 RAMELTEON 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-505 RAMELTEON TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 3 Current NDC, 2 package rows 20240521_01dfc4c5-07d1-4dd7-a9ca-a94203b2e16d.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 · 3 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 59651-505-01 59651050501 100 TABLET, FILM COATED in 1 BOTTLE (59651-505-01) 2023-07-10 No No Current 59651-505-30 59651050530 30 TABLET, FILM COATED in 1 BOTTLE (59651-505-30) 2023-07-10 No No Current