FDA.reportPublic FDA data

NDC 80425-0203-01 - Ramelteon

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0203
Requested NDC
80425-0203-01
Package NDCs from labels
80425-0203-1, 80425-0203-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ramelteon - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0203-1Ramelteon30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0203RAMELTEON TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, Legacy NDC, 1 package rows20250101_ed37ac7c-ab7e-57b3-e053-2995a90a5b90.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0203-1EA - Each80425-02036a0e5529-6bc0-4142-8df7-681d94dc4b7712023-06-06

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
unii: 901AS54I69
RamelteonRAMELTEONAdvanced Rx of Tennessee, LLC57b24572-f601-b092-e063-6394a90afa532026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONSportpharm LLCb4239d09-2cb3-4e7d-b035-995ddcf386df2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONMarlex Pharmaceuticals, Inc.56d1ac8d-5131-4eed-e063-6294a90a402e2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONAvPAK5245f9ee-b4ca-24b6-e063-6394a90a0b1b2026-05-27Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONBryant Ranch Prepack00f0fbda-eb62-4f79-ae9c-286b31eca7332026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONASCLEMED USA INC.f15c8612-4065-4078-bff9-f2ffc13196542026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RozeremRAMELTEONTakeda Pharmaceuticals America, Inc.9de82310-70e8-47b9-b1fc-6c6848b994552026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONKanchan Healthcare Inc782503c6-a82f-4933-aa04-399123e9f5a92026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONBryant Ranch Prepack86296f99-efef-4cbb-84cb-097b2edcfe9c2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONMajor Pharmaceuticals44be28b2-f079-40ce-b86d-8b60eda1a7c02026-03-16Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONAvKAREb6fc0db5-c68f-5af9-e053-2a95a90a51102026-01-15Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONUpsher-Smith Laboratories, LLC2d22e6ae-2373-4a2f-8dda-d223230c60102026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONBryant Ranch Prepackb1706aa1-9332-4faf-8d0c-88edd00b15e32025-10-28Warnings, Adverse reactionsExact identifier
application number: ANDA212650
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONBryant Ranch Prepack3c14d79c-ece1-40c7-b725-eeb85d6f347a2025-10-20Warnings, Adverse reactionsExact identifier
application number: ANDA212650
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONMicro Labs Limited7545c79a-93ea-4f73-beb5-cac46b2ed7e92025-04-23Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONProficient Rx LP2cb1b48a-05c0-4058-8ccd-1971098b8ce12025-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA212650
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONDirect_Rxe55aea01-80e6-60ae-e053-2995a90a9ca22025-01-22Warnings, Adverse reactionsExact identifier
application number: ANDA212650
rxcui: 577348
unii: 901AS54I69
RamelteonRAMELTEONDirect_Rxfd169dd8-70a0-b6b4-e053-6394a90a3a6f2025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69
RAMELTEONRAMELTEONDIRECT RXb336438f-7951-d3b7-e053-2995a90a4d692025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 577348
unii: 901AS54I69

Reported adverse events (FAERS/openFDA)#

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