FDA.reportPublic FDA data

RAMELTEON - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2024-08-09
Label type
Indexing - Product Concept
Version
8
Source
full-release
Hydrated at
2026-06-05 00:24:01

Label at a glance#

ProductRAMELTEON
Active ingredientRAMELTEON

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
RAMELTEON901AS54I69ACTIB

Source Document#

Source XML

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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamelteonRAMELTEONREMEDYREPACK INC.5a3cf917-3569-4fc1-8b81-ffecfd2de0052026-09-01Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONAdvanced Rx of Tennessee, LLC57b24572-f601-b092-e063-6394a90afa532026-07-27Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONSportpharm LLCb4239d09-2cb3-4e7d-b035-995ddcf386df2026-07-21Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONMarlex Pharmaceuticals, Inc.56d1ac8d-5131-4eed-e063-6294a90a402e2026-07-01Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONAvPAK5245f9ee-b4ca-24b6-e063-6394a90a0b1b2026-05-27Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONBryant Ranch Prepack00f0fbda-eb62-4f79-ae9c-286b31eca7332026-05-07Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONASCLEMED USA INC.f15c8612-4065-4078-bff9-f2ffc13196542026-05-07Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RozeremRAMELTEONTakeda Pharmaceuticals America, Inc.9de82310-70e8-47b9-b1fc-6c6848b994552026-04-15Warnings, Adverse reactionsName fallback
generic name: RAMELTEON
RamelteonRAMELTEONKanchan Healthcare Inc782503c6-a82f-4933-aa04-399123e9f5a92026-04-01Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONBryant Ranch Prepack86296f99-efef-4cbb-84cb-097b2edcfe9c2026-03-19Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONMajor Pharmaceuticals44be28b2-f079-40ce-b86d-8b60eda1a7c02026-03-16Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONAvKAREb6fc0db5-c68f-5af9-e053-2a95a90a51102026-01-15Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONUpsher-Smith Laboratories, LLC2d22e6ae-2373-4a2f-8dda-d223230c60102026-01-08Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONBryant Ranch Prepackb1706aa1-9332-4faf-8d0c-88edd00b15e32025-10-28Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONBryant Ranch Prepack3c14d79c-ece1-40c7-b725-eeb85d6f347a2025-10-20Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONMicro Labs Limited7545c79a-93ea-4f73-beb5-cac46b2ed7e92025-04-23Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONProficient Rx LP2cb1b48a-05c0-4058-8ccd-1971098b8ce12025-04-01Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONDirect_Rxe55aea01-80e6-60ae-e053-2995a90a9ca22025-01-22Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RamelteonRAMELTEONDirect_Rxfd169dd8-70a0-b6b4-e053-6394a90a3a6f2025-01-22Warnings, Adverse reactionsName fallback
brand name: Ramelteon
generic name: RAMELTEON
RAMELTEONRAMELTEONDIRECT RXb336438f-7951-d3b7-e053-2995a90a4d692025-01-17Warnings, Adverse reactionsName fallback
brand name: RAMELTEON
generic name: RAMELTEON

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.