FDA.reportPublic FDA data

ramelteon 8 MG Oral Tablet

RxCUI
577348
RxNorm name
ramelteon 8 MG Oral Tablet
Display name
ramelteon 8 MG Oral Tablet
Full name
ramelteon 8 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamelteonRAMELTEONREMEDYREPACK INC.5a3cf917-3569-4fc1-8b81-ffecfd2de0052026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONAdvanced Rx of Tennessee, LLC57b24572-f601-b092-e063-6394a90afa532026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONSportpharm LLCb4239d09-2cb3-4e7d-b035-995ddcf386df2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONMarlex Pharmaceuticals, Inc.56d1ac8d-5131-4eed-e063-6294a90a402e2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONAvPAK5245f9ee-b4ca-24b6-e063-6394a90a0b1b2026-05-27Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONBryant Ranch Prepack00f0fbda-eb62-4f79-ae9c-286b31eca7332026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONASCLEMED USA INC.f15c8612-4065-4078-bff9-f2ffc13196542026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 577348
RozeremRAMELTEONTakeda Pharmaceuticals America, Inc.9de82310-70e8-47b9-b1fc-6c6848b994552026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONKanchan Healthcare Inc782503c6-a82f-4933-aa04-399123e9f5a92026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONBryant Ranch Prepack86296f99-efef-4cbb-84cb-097b2edcfe9c2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONMajor Pharmaceuticals44be28b2-f079-40ce-b86d-8b60eda1a7c02026-03-16Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONAvKAREb6fc0db5-c68f-5af9-e053-2a95a90a51102026-01-15Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONUpsher-Smith Laboratories, LLC2d22e6ae-2373-4a2f-8dda-d223230c60102026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONBryant Ranch Prepackb1706aa1-9332-4faf-8d0c-88edd00b15e32025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONBryant Ranch Prepack3c14d79c-ece1-40c7-b725-eeb85d6f347a2025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONMicro Labs Limited7545c79a-93ea-4f73-beb5-cac46b2ed7e92025-04-23Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONProficient Rx LP2cb1b48a-05c0-4058-8ccd-1971098b8ce12025-04-01Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONDirect_Rxe55aea01-80e6-60ae-e053-2995a90a9ca22025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 577348
RamelteonRAMELTEONDirect_Rxfd169dd8-70a0-b6b4-e053-6394a90a3a6f2025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 577348
RAMELTEONRAMELTEONDIRECT RXb336438f-7951-d3b7-e053-2995a90a4d692025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 577348

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 45 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f15c8612-4065-4078-bff9-f2ffc1319654ramelteon 8 MG Oral Tablet [PSN] · ramelteon 8 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 200520260507
782503c6-a82f-4933-aa04-399123e9f5a9ramelteon 8 MG Oral Tablet [PSN] · ramelteon 8 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 200520260401
8213998f-9a14-4ebb-a87a-4f33416dfb21ramelteon 8 MG Oral Tablet [PSN] · ramelteon 8 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 200520250117
7b9b6076-180e-428b-b50a-5ab68ff65919ramelteon 8 MG Oral Tablet [PSN] · ramelteon 8 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 200520240610
7a51d289-2013-4d37-adf2-91ea49df7932ramelteon 8 MG Oral Tablet [PSN] · ramelteon 8 MG Oral Tablet [SCD]2120100120