Prescription drug · NDA
Seroquel XR (Quetiapine) NDC 0310-0282
Quetiapine fumarate 200 mg/1 · Tablet, Extended release · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-0282-60 | 0031002826000310028260 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0282-60)Marketed from Jul 16, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Seroquel XRSuffix: XR
- Generic name (nonproprietary)
- quetiapine
- Active ingredients
- Quetiapine fumarate — 200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022047
- Marketing start
- Marketing end
- Identifiers
- Product ID 0310-0282_8e78eabf-6ff9-409b-ba1b-d9cb8d4f3fe0SPL ID 8e78eabf-6ff9-409b-ba1b-d9cb8d4f3fe0SPL set ID 473a3ac4-67f4-4782-baa9-7f9bdd8761f4RxCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671UNII 2S3PL1B6UJ
- Pharmacologic class
- Atypical Antipsychotic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400310028260followed by a unit qualifier and the quantityPackage 00310-0282-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
SEROQUEL XR is an atypical antipsychotic indicated for the treatment of: • Schizophrenia (1.1) • Bipolar I disorder, manic, or mixed episodes (1.2) • Bipolar disorder, depressive episodes (1.2) • Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with SEROQUEL [see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder SE…
Excerpt only. Read the full label for complete information.
About NDC 0310-0282
- What is NDC 0310-0282?
- 0310-0282 is the product NDC for Seroquel XR (quetiapine), Quetiapine fumarate 200 mg/1 tablet, extended release, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Seroquel XR (Quetiapine).
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Seroquel XR?
- 8 other product NDCs are listed under this name. See all Seroquel XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Seroquel XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Seroquel XRquetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-0281 | 00310-0281-60 |
| Seroquel XRquetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-270 | 61269-0270-60 |
| Seroquel XRquetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-271 | 61269-0271-60 |
| Seroquel XRquetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-0283 | 00310-0283-60 |
| Seroquel XRquetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-0284 | 00310-0284-60 |
| Seroquel XRquetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-272 | 61269-0272-60 |
| Seroquel XRquetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-273 | 61269-0273-60 |
| Seroquel XRquetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-274 | 61269-0274-60 |
Other NDCs under NDA 022047
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Seroquel XRquetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-0281 |
| Seroquel XRquetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-0283 |
| Seroquel XRquetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-0284 |
| Seroquel XRquetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-270 |
| Seroquel XRquetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-271 |
| Seroquel XRquetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-272 |
| Seroquel XRquetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-273 |
| Seroquel XRquetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-274 |