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NDC 53002-1516-00 Quetiapine 100 mg/1 Details
Quetiapine 100 mg/1
Quetiapine is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is QUETIAPINE FUMARATE.
MedlinePlus Drug Summary
Quetiapine tablets and extended-release (long-acting) tablets are used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Quetiapine tablets and extended-release tablets are also used alone or with other medications to treat episodes of mania (frenzied, abnormally excited or irritated mood) or depression in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). In addition, quetiapine tablets and extended-release tablets are used with other medications to prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine extended-release tablets are also used along with other medications to treat depression. Quetiapine tablets may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children and teenagers. Quetiapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Related Packages: 53002-1516-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Quetiapine
Product Information
| NDC | 53002-1516 |
|---|---|
| Product ID | 53002-1516_3ef419af-7f9a-46a5-9a0d-6c7966a9d37c |
| Associated GPIs | |
| 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 | Quetiapine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Quetiapine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | QUETIAPINE FUMARATE |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202152 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1516-00 (53002151600)
| NDC Package Code | 53002-1516-0 |
|---|---|
| Billing NDC | 53002151600 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (53002-1516-0) |
| Marketing Start Date | 2019-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |