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Rozerem
Rozerem - 64764-805-10 - (ramelteon)
Drug Information of Rozerem
| Product NDC: | 64764-805 |
| Proprietary Name: | Rozerem |
| Non Proprietary Name: | ramelteon |
| Active Ingredient(s): | 8 mg/1 & nbsp; ramelteon |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Rozerem
| Product NDC: | 64764-805 |
| Labeler Name: | Takeda Pharmaceuticals America, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021782 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20050722 |
Package Information of Rozerem
| Package NDC: | 64764-805-10 |
| Package Description: | 100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10) |
NDC Information of Rozerem
| NDC Code | 64764-805-10 |
| Proprietary Name | Rozerem |
| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10) |
| Product NDC | 64764-805 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ramelteon |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20050722 |
| Marketing Category Name | NDA |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Substance Name | RAMELTEON |
| Strength Number | 8 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] |
