Quetiapine Extended-Release is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Alignscience Pharma Inc.. The primary component is Quetiapine Fumarate.
| Product ID | 69948-003_7366858f-2734-4214-a5ba-66307182fd62 |
| NDC | 69948-003 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Quetiapine Extended-Release |
| Generic Name | Quetiapine |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-03-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA209497 |
| Labeler Name | AlignScience Pharma Inc. |
| Substance Name | QUETIAPINE FUMARATE |
| Active Ingredient Strength | 200 mg/1 |
| Pharm Classes | Atypical Antipsychotic [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-03-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA209497 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-03-31 |
| Marketing Category | ANDA |
| Application Number | ANDA209497 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-03-31 |
| Ingredient | Strength |
|---|---|
| QUETIAPINE FUMARATE | 200 mg/1 |
| SPL SET ID: | db3ba268-21a2-4988-b5c1-353741bcaee5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 69948-002 | Quetiapine Extended-Release | Quetiapine Extended-Release |
| 69948-003 | Quetiapine Extended-Release | Quetiapine Extended-Release |
| 0093-2063 | Quetiapine | Quetiapine |
| 0093-8162 | Quetiapine | Quetiapine |
| 0093-8163 | Quetiapine | Quetiapine |
| 0093-8164 | Quetiapine | Quetiapine |
| 0093-8165 | Quetiapine | Quetiapine |
| 0093-8166 | Quetiapine | Quetiapine |
| 0310-0271 | SEROQUEL | quetiapine |