Home NDC 85742-023 Ramelteon
Product NDC 85742-023
11-digit product format 857420023
Labeler code 85742
Product ID 85742-023_cb93cc24-9441-4f57-ad46-92f2f09ccc02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramelteon
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kanchan Healthcare Inc
Application ANDA215435
Marketing category ANDA
Marketing start 2026-04-21
Substance RAMELTEON
Active strength 8 mg/1
Pharmacologic classes Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A215435-001 RAMELTEON RAMELTEON 8MG TABLET / ORAL AB 2022-08-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215435-001 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 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215435-001 RAMELTEON 8MG TABLET / ORAL 2022-08-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215435-001 RAMELTEON 8MG TABLET / ORAL AB 2022-08-24 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ramelteon
Listing expiration 2027-12-31 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 85742-023-22 Ramelteon 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1 85742-023-23 Ramelteon 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 1
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 85742-023-22 85742002322 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85742-023-22) 2026-04-21 No No Current 85742-023-23 85742002323 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85742-023-23) 2026-04-21 No No Current