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.
| Product ID | 53002-1529_3c1bff09-132e-4dc1-8f1f-03df04fd90fd |
| NDC | 53002-1529 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Quetiapine |
| Generic Name | Quetiapine |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-03-28 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202152 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Substance Name | QUETIAPINE FUMARATE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Atypical Antipsychotic [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202152 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| QUETIAPINE FUMARATE | 50 mg/1 |
| SPL SET ID: | 14827341-d940-493f-9598-2d129436b5ec |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-2063 | Quetiapine | Quetiapine |
| 0093-8162 | Quetiapine | Quetiapine |
| 0093-8163 | Quetiapine | Quetiapine |
| 0093-8164 | Quetiapine | Quetiapine |
| 0093-8165 | Quetiapine | Quetiapine |
| 0093-8166 | Quetiapine | Quetiapine |
| 68071-2038 | Quetiapine | Quetiapine |
| 68071-4161 | Quetiapine | Quetiapine |
| 68788-7185 | Quetiapine | Quetiapine |
| 68788-7184 | Quetiapine | Quetiapine |
| 68788-7186 | Quetiapine | Quetiapine |
| 68788-7412 | Quetiapine | Quetiapine |
| 70518-0229 | Quetiapine | Quetiapine |
| 70518-0239 | Quetiapine | Quetiapine |
| 70518-0289 | Quetiapine | Quetiapine |
| 70518-0345 | Quetiapine | Quetiapine |
| 70518-0432 | Quetiapine | Quetiapine |
| 70518-0889 | Quetiapine | Quetiapine |
| 70518-0808 | Quetiapine | Quetiapine |
| 70518-0825 | Quetiapine | Quetiapine |
| 70518-0570 | Quetiapine | Quetiapine |
| 70518-0752 | Quetiapine | Quetiapine |
| 70518-1477 | Quetiapine | Quetiapine |
| 70518-1569 | Quetiapine | Quetiapine |
| 71205-026 | Quetiapine | Quetiapine |
| 71335-0432 | Quetiapine | Quetiapine |
| 0615-7987 | Quetiapine | Quetiapine |
| 0615-7988 | Quetiapine | Quetiapine |
| 0615-7986 | Quetiapine | Quetiapine |
| 0615-8119 | Quetiapine | Quetiapine |
| 16714-452 | Quetiapine | Quetiapine |
| 16729-145 | Quetiapine | Quetiapine |
| 16714-455 | Quetiapine | Quetiapine |
| 16729-147 | Quetiapine | Quetiapine |
| 16714-456 | Quetiapine | Quetiapine |
| 16714-453 | Quetiapine | Quetiapine |
| 16714-457 | Quetiapine | Quetiapine |
| 16729-146 | Quetiapine | Quetiapine |
| 16729-149 | Quetiapine | Quetiapine |
| 16714-454 | Quetiapine | Quetiapine |
| 16729-150 | Quetiapine | Quetiapine |
| 16729-148 | Quetiapine | Quetiapine |
| 33342-135 | QUETIAPINE | QUETIAPINE |
| 33342-137 | QUETIAPINE | QUETIAPINE |
| 33342-134 | QUETIAPINE | QUETIAPINE |
| 33342-136 | QUETIAPINE | QUETIAPINE |
| 50090-2831 | Quetiapine | Quetiapine |
| 50090-2307 | Quetiapine | Quetiapine |
| 50090-2690 | Quetiapine | Quetiapine |
| 50090-2830 | Quetiapine | Quetiapine |