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NDC 53002-1305-00 Fluoxetine 10 mg/1 Details
Fluoxetine 10 mg/1
Fluoxetine is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is FLUOXETINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Fluoxetine is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks). Fluoxetine is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. It is also used along with olanzapine (Zyprexa) to treat depression that did not respond to other medications and episodes of depression in people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
Related Packages: 53002-1305-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoxetine
Product Information
| NDC | 53002-1305 |
|---|---|
| Product ID | 53002-1305_7c0522b2-5aed-43ba-a593-3e7bdd618845 |
| Associated GPIs | 58160040000110 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Fluoxetine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluoxetine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | FLUOXETINE HYDROCHLORIDE |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078619 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1305-00 (53002130500)
| NDC Package Code | 53002-1305-0 |
|---|---|
| Billing NDC | 53002130500 |
| Package | 100 CAPSULE in 1 BOTTLE (53002-1305-0) |
| Marketing Start Date | 2017-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |