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NDC 60505-4665-03 Tasimelteon 20 mg/1 Details
Tasimelteon 20 mg/1
Tasimelteon is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is TASIMELTEON.
MedlinePlus Drug Summary
Tasimelteon is used to treat non-24-hour sleep-wake disorder (non-24; a condition that occurs mainly in people who are blind in which the body's natural clock is out of sync with the normal day-night cycle and causes a disrupted sleep schedule) in adults. It is also used to treat nighttime sleep problems in adults and children 3 years of age and older with Smith-Magenis Syndrome (SMS; a developmental disorder). Tasimelteon 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: 60505-4665-03Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Tasimelteon
Product Information
| NDC | 60505-4665 |
|---|---|
| Product ID | 60505-4665_2d32bb85-3df0-b9c6-0fd1-bf559cdc6550 |
| Associated GPIs | |
| GCN Sequence Number | 072007 |
| GCN Sequence Number Description | tasimelteon CAPSULE 20 MG ORAL |
| HIC3 | H8B |
| HIC3 Description | HYPNOTICS, MELATONIN MT1/MT2 RECEPTOR AGONISTS |
| GCN | 36068 |
| HICL Sequence Number | 040927 |
| HICL Sequence Number Description | TASIMELTEON |
| Brand/Generic | Generic |
| Proprietary Name | Tasimelteon |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tasimelteon |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/1 |
| Substance Name | TASIMELTEON |
| Labeler Name | Apotex Corp. |
| Pharmaceutical Class | Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211607 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 60505-4665-03 (60505466503)
| NDC Package Code | 60505-4665-3 |
|---|---|
| Billing NDC | 60505466503 |
| Package | 30 CAPSULE in 1 BOTTLE (60505-4665-3) |
| Marketing Start Date | 2024-01-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |