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NDC 69238-2548-03 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 Amneal Pharmaceuticals NY LLC. 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: 69238-2548-03Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Tasimelteon
Product Information
| NDC | 69238-2548 |
|---|---|
| Product ID | 69238-2548_071804f4-9647-4a4d-a394-55b9e976dc9f |
| 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 | Amneal Pharmaceuticals NY LLC |
| Pharmaceutical Class | Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211654 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69238-2548-03 (69238254803)
| NDC Package Code | 69238-2548-3 |
|---|---|
| Billing NDC | 69238254803 |
| Package | 30 CAPSULE in 1 BOTTLE (69238-2548-3) |
| Marketing Start Date | 2023-02-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |