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NDC 64764-0805-30 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: 64764-0805-30Last 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 64764-0805-30 (64764080530)
| NDC Package Code | 64764-805-30 |
|---|---|
| Billing NDC | 64764080530 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30) |
| Marketing Start Date | 2005-07-22 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 12.434 |
| Pricing Unit | EA |
| Effective Date | 2023-12-20 |
| NDC Description | ROZEREM 8 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 2 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis