Home NDC 76420-880 RAMELTEON
Product NDC 76420-880
11-digit product format 764200880
Labeler code 76420
Product ID 76420-880_2bea370a-97da-d286-e063-6294a90aca7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RAMELTEON
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Asclemed USA, Inc.
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 76420-880-01 RAMELTEON 100 in 1 BOTTLE TABLET, FILM COATED 100 1 76420-880-30 RAMELTEON 30 in 1 BOTTLE TABLET, FILM COATED 30 1 76420-880-60 RAMELTEON 60 in 1 BOTTLE TABLET, FILM COATED 60 1 76420-880-90 RAMELTEON 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-880 RAMELTEON TABLET, FILM COATED [ASCLEMED USA, INC.] 1 Current NDC, 4 package rows 20250122_8213998f-9a14-4ebb-a87a-4f33416dfb21.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 76420-880-01 76420088001 100 TABLET, FILM COATED in 1 BOTTLE (76420-880-01) 2025-01-17 No No Current 76420-880-30 76420088030 30 TABLET, FILM COATED in 1 BOTTLE (76420-880-30) 2025-01-17 No No Current 76420-880-60 76420088060 60 TABLET, FILM COATED in 1 BOTTLE (76420-880-60) 2025-01-17 No No Current 76420-880-90 76420088090 90 TABLET, FILM COATED in 1 BOTTLE (76420-880-90) 2025-01-17 No No Current