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NDC 64764-0805-22 Rozerem 8 mg/1 Details
Rozerem 8 mg/1
Rozerem is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is RAMELTEON.
MedlinePlus Drug Summary
Ramelteon is used to help patients who have sleep-onset insomnia (difficulty falling asleep) fall asleep more quickly. Ramelteon is in a class of medications called melatonin receptor agonists. It works similarly to melatonin, a natural substance in the brain that is needed for sleep.
Related Packages: 64764-0805-22Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ramelteon
Product Information
| NDC | 64764-0805 |
|---|---|
| Product ID | 64764-805_2dd3b589-791d-4151-8d80-357f6144d565 |
| Associated GPIs | 60250060000320 |
| GCN Sequence Number | 059509 |
| GCN Sequence Number Description | ramelteon TABLET 8 MG ORAL |
| HIC3 | H8B |
| HIC3 Description | HYPNOTICS, MELATONIN MT1/MT2 RECEPTOR AGONISTS |
| GCN | 25202 |
| HICL Sequence Number | 033126 |
| HICL Sequence Number Description | RAMELTEON |
| Brand/Generic | Brand |
| Proprietary Name | Rozerem |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ramelteon |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 8 |
| Active Ingredient Units | mg/1 |
| Substance Name | RAMELTEON |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021782 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64764-0805-22 (64764080522)
| NDC Package Code | 64764-805-22 |
|---|---|
| Billing NDC | 64764080522 |
| Package | 6 CARTON in 1 TRAY (64764-805-22) / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2005-07-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |