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NDC 54766-0907-53 BRISDELLE 7.5 mg/1 Details
BRISDELLE 7.5 mg/1
BRISDELLE is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is PAROXETINE MESYLATE.
MedlinePlus Drug Summary
Paroxetine tablets, suspension (liquid), and extended-release (long-acting) tablets are used to treat depression, panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). Paroxetine tablets and suspension are also used to treat obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), generalized anxiety disorder (GAD; excessive worrying that is difficult to control), and posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience). Paroxetine extended-release tablets are also used to treat premenstrual dysphoric disorder (PMDD, physical and psychological symptoms that occur before the onset of the menstrual period each month). Paroxetine capsules (Brisdelle) are used to treat hot flashes (sudden feelings of warmth, especially in the face, neck, and chest) in women who are experiencing menopause (stage of life when menstrual periods become less frequent and stop and women may experience other symptoms and body changes). Paroxetine is in a class of medications called selective serotonin-reuptake inhibitors (SSRIs). It treats depression and other mental illnesses by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance. There is not enough information available at this time to know how paroxetine works to treat hot flashes.
Related Packages: 54766-0907-53Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Paroxetine
Product Information
NDC | 54766-0907 |
---|---|
Product ID | 54766-907_e190f18a-ef9d-7e9e-e053-2995a90af934 |
Associated GPIs | 62226060300110 |
GCN Sequence Number | 071167 |
GCN Sequence Number Description | paroxetine mesylate CAPSULE 7.5 MG ORAL |
HIC3 | G6A |
HIC3 Description | MENOPAUSAL SYMPTOMS SUPPRESSANT - SSRIS |
GCN | 34876 |
HICL Sequence Number | 025796 |
HICL Sequence Number Description | PAROXETINE MESYLATE |
Brand/Generic | Brand |
Proprietary Name | BRISDELLE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | paroxetine |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | CAPSULE |
Route | ORAL |
Active Ingredient Strength | 7.5 |
Active Ingredient Units | mg/1 |
Substance Name | PAROXETINE MESYLATE |
Labeler Name | Sebela Pharmaceuticals Inc. |
Pharmaceutical Class | Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA204516 |
Listing Certified Through | n/a |
Package
NDC 54766-0907-53 (54766090753)
NDC Package Code | 54766-907-53 |
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Billing NDC | 54766090753 |
Package | 30 CAPSULE in 1 BLISTER PACK (54766-907-53) |
Marketing Start Date | 2017-05-23 |
NDC Exclude Flag | N |
Pricing Information | N/A |