Ramelteon is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by I3 Pharmaceuticals, Llc. The primary component is Ramelteon.
| Product ID | 72319-005_8a1d1877-4758-4d82-b1a7-810d2a558a44 |
| NDC | 72319-005 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ramelteon |
| Generic Name | Ramelteon |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-04-30 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA212650 |
| Labeler Name | i3 Pharmaceuticals, LLC |
| Substance Name | RAMELTEON |
| Active Ingredient Strength | 8 mg/1 |
| Pharm Classes | Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-04-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA212650 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA212650 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA212650 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-04-30 |
| Ingredient | Strength |
|---|---|
| RAMELTEON | 8 mg/1 |
| SPL SET ID: | 32c52e03-4c2e-4774-9397-f1f0ee99b320 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0591-2191 | Ramelteon | Ramelteon |
| 0832-1250 | Ramelteon | Ramelteon |
| 42291-776 | Ramelteon | Ramelteon |
| 43598-741 | Ramelteon | Ramelteon |
| 50268-708 | Ramelteon | Ramelteon |
| 50436-3980 | Ramelteon | Ramelteon |
| 51407-375 | Ramelteon | Ramelteon |
| 52817-235 | Ramelteon | Ramelteon |
| 55700-874 | Ramelteon | Ramelteon |
| 63629-8264 | Ramelteon | Ramelteon |
| 63629-8531 | Ramelteon | Ramelteon |
| 70010-028 | Ramelteon | Ramelteon |
| 70710-1344 | Ramelteon | Ramelteon |
| 70771-1495 | Ramelteon | Ramelteon |
| 71205-918 | Ramelteon | Ramelteon |
| 71335-1853 | Ramelteon | Ramelteon |
| 71335-2186 | Ramelteon | Ramelteon |
| 72189-153 | RAMELTEON | RAMELTEON |
| 72189-369 | Ramelteon | Ramelteon |
| 72319-005 | Ramelteon | Ramelteon |
| 80425-0203 | Ramelteon | Ramelteon |
| 21695-183 | Rozerem | ramelteon |
| 63629-3389 | Rozerem | ramelteon |
| 64764-805 | Rozerem | ramelteon |
| 68151-4881 | Rozerem | ramelteon |