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 | Type |
|---|---|---|---|
| Ramelteon - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0203-1 | Ramelteon | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0203 | RAMELTEON TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250101_ed37ac7c-ab7e-57b3-e053-2995a90a5b90.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0203-1 | EA - Each | 80425-0203 | 6a0e5529-6bc0-4142-8df7-681d94dc4b77 | 1 | 2023-06-06 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| RAMELTEON | RAMELTEON | Asclemed USA, Inc. | 8213998f-9a14-4ebb-a87a-4f33416dfb21 | 2025-01-17 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Advanced Rx Pharmacy of Tennessee, LLC | ed37ac7c-ab7e-57b3-e053-2995a90a5b90 | 2024-12-31 | Warnings, Adverse reactions | ANDA212650 80425-0203-1 80425-0203 80425020301 577348 2a99c981-daf6-71e5-e063-6294a90a5c1d ed37ac7c-ab7e-57b3-e053-2995a90a5b90 901AS54I69 |
| Ramelteon | RAMELTEON | Advanced Rx Pharmacy of Tennessee, LLC | fe2fc3b7-4600-c14e-e053-6394a90a2586 | 2024-12-31 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Zydus Lifesciences Limited | 14ba7994-476a-4978-8cac-29989335a63c | 2024-12-04 | 577348 901AS54I69 | |
| Ramelteon | RAMELTEON | Golden State Medical Supply, Inc. | 229403c5-de9c-dc61-e063-6394a90a2a70 | 2024-09-20 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | American Health Packaging | 094d5aa0-aa29-4898-928a-fe0d283a5271 | 2024-07-19 | Warnings, Adverse reactions | 577348 901AS54I69 |
| RAMELTEON | RAMELTEON | Bryant Ranch Prepack | 7b9b6076-180e-428b-b50a-5ab68ff65919 | 2024-06-10 | Warnings, Adverse reactions | 577348 901AS54I69 |
| RAMELTEON | RAMELTEON | Aurobindo Pharma Limited | 01dfc4c5-07d1-4dd7-a9ca-a94203b2e16d | 2024-05-17 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Bryant Ranch Prepack | af1db3bf-1c7c-441e-8497-7c35f45fb00e | 2024-04-04 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Bryant Ranch Prepack | 4c25cf94-f30e-4940-9f8b-3cb34258ba04 | 2023-12-18 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Bryant Ranch Prepack | 57536bd9-7dfa-4be5-854a-95fea43d54bc | 2023-12-07 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Asclemed USA, Inc. | 208dbac2-2634-4aff-8e2c-e5ecb47145e2 | 2023-11-27 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Bryant Ranch Prepack | bccc4f11-6081-49a1-9abd-2f4c2d69b380 | 2023-11-09 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Bryant Ranch Prepack | 4d6ad234-69ae-4e33-824d-cff5d1500a86 | 2023-11-09 | Warnings, Adverse reactions | ANDA212650 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Zydus Pharmaceuticals USA Inc. | 5db0e3ff-fefb-4c54-b9f9-b555e482e147 | 2023-11-07 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Granules Pharmaceuticals Inc. | a0a57843-81cb-474d-8e90-e04bbe93216a | 2023-07-28 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | i3 Pharmaceuticals, LLC | 32c52e03-4c2e-4774-9397-f1f0ee99b320 | 2023-04-28 | Warnings, Adverse reactions | ANDA212650 577348 901AS54I69 |
| Ramelteon | RAMELTEON | TruPharma, LLC | 3d0cc378-4bc5-425c-8f41-43eb734c24d9 | 2023-04-28 | Warnings, Adverse reactions | ANDA212650 52817-235 577348 06ea67d8-b615-776b-e063-6294a90a3185 3d0cc378-4bc5-425c-8f41-43eb734c24d9 901AS54I69 |
| Ramelteon | RAMELTEON | Proficient Rx LP | 7ca849d3-f0ba-45b5-9aec-f4b7ea105fac | 2022-04-01 | Warnings, Adverse reactions | 577348 901AS54I69 |
| Ramelteon | RAMELTEON | Actavis Pharma, Inc. | a89dae05-6c39-4072-b8ee-c4c35b46f7d4 | 2022-03-01 | Warnings, Adverse reactions | 577348 901AS54I69 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.