Home NDC 50268-708-15 Ramelteon
Product NDC 50268-708
Requested package NDC 50268-708-15
11-digit product format 502680708
Labeler code 50268
Product ID 50268-708_3a9a3e15-b992-ab32-e063-6294a90aab3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramelteon
Dosage form TABLET
Route ORAL
Labeler AvPAK
Application ANDA091693
Marketing category ANDA
Marketing start 2021-01-06
Marketing end 2026-07-09
Substance RAMELTEON
Active strength 8 mg/1
Pharmacologic classes Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag No
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 A091693-001 RAMELTEON RAMELTEON 8MG TABLET / ORAL AB 2013-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091693-001 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.
Product history page 1 of 2 · 41 observed 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 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091693-001 RAMELTEON 8MG TABLET / ORAL AB 2013-07-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50268-708-11 Ramelteon 1 in 1 BLISTER PACK TABLET 1 5 50268-708-15 Ramelteon 50 in 1 BOX TABLET 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-708 RAMELTEON TABLET [AVPAK] 4 Current NDC, Legacy NDC, 2 package rows 20250112_b83cb374-8b38-1e35-e053-2995a90aa527.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-708-15 50268070815 50 BLISTER PACK in 1 BOX (50268-708-15) / 1 TABLET in 1 BLISTER PACK (50268-708-11) 50 blister pack 2021-01-06 2026-07-09 No No Current