NDC 0310-0283
SEROQUEL XR
Quetiapine Fumarate
SEROQUEL XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Quetiapine Fumarate.
| Product ID | 0310-0283_130a4121-4ea4-463e-8ba3-e30f35455f1d |
| NDC | 0310-0283 |
| Product Type | Human Prescription Drug |
| Proprietary Name | SEROQUEL XR |
| Generic Name | Quetiapine Fumarate |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2007-07-16 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022047 |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Substance Name | QUETIAPINE FUMARATE |
| Active Ingredient Strength | 300 mg/1 |
| Pharm Classes | Atypical Antipsychotic [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0310-0283-60
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0283-60)
| Marketing Start Date | 2007-07-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0310-0283-55 [00310028355]
SEROQUEL XR TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA022047 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2007-07-16 |
| Marketing End Date | 2012-05-28 |
NDC 0310-0283-39 [00310028339]
SEROQUEL XR TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA022047 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2007-07-16 |
| Marketing End Date | 2020-09-30 |
NDC 0310-0283-50 [00310028350]
SEROQUEL XR TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA022047 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2007-07-16 |
| Marketing End Date | 2011-03-23 |
NDC 0310-0283-94 [00310028394]
SEROQUEL XR TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA022047 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2007-07-16 |
| Marketing End Date | 2020-01-31 |
NDC 0310-0283-60 [00310028360]
SEROQUEL XR TABLET, EXTENDED RELEASE
| Marketing Category | NDA |
| Application Number | NDA022047 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2007-07-16 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| QUETIAPINE FUMARATE | 300 mg/1 |
OpenFDA Data
| SPL SET ID: | 473a3ac4-67f4-4782-baa9-7f9bdd8761f4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Atypical Antipsychotic [EPC]
NDC Crossover Matching brand name "SEROQUEL XR" or generic name "Quetiapine Fumarate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 69189-0484 | SEROQUEL XR | SEROQUEL XR |
| 0310-0281 | SEROQUEL XR | SEROQUEL XR |
| 0310-0284 | SEROQUEL XR | SEROQUEL XR |
| 0310-0282 | SEROQUEL XR | SEROQUEL XR |
| 0310-0297 | SEROQUEL XR | SEROQUEL XR |
| 0310-0280 | SEROQUEL XR | SEROQUEL XR |
| 0310-0283 | SEROQUEL XR | SEROQUEL XR |
| 64725-0281 | SEROQUEL XR | SEROQUEL XR |
| 64725-0282 | SEROQUEL XR | SEROQUEL XR |
| 64725-0280 | SEROQUEL XR | SEROQUEL XR |
| 64725-0284 | SEROQUEL XR | SEROQUEL XR |
| 64725-0283 | SEROQUEL XR | SEROQUEL XR |
| 0054-0220 | Quetiapine Fumarate | Quetiapine Fumarate |
| 0054-0221 | Quetiapine Fumarate | Quetiapine Fumarate |
| 0054-0222 | Quetiapine Fumarate | Quetiapine Fumarate |
| 0054-0223 | Quetiapine Fumarate | Quetiapine Fumarate |
| 0054-0229 | Quetiapine Fumarate | Quetiapine Fumarate |
| 0054-0230 | Quetiapine Fumarate | Quetiapine Fumarate |
Trademark Results [SEROQUEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEROQUEL 73724400 1517746 Live/Registered |
IMPERIAL CHEMICAL INDUSTRIES PLC 1988-04-25 |
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