Prescription drug · NDA
Seroquel XR (quetiapine) NDC 61269-271
Quetiapine fumarate 150 mg/1 · Tablet, Extended release · Oral · H2-Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-271-60 | 61269027160 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61269-271-60)Marketed from Feb 1, 2009 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 150 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- H2-Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022047
- Marketing start
- Listing expires
- Identifiers
- Product ID 61269-271_30d64c02-e070-43b8-9c96-3f7b112c5f7cSPL ID 30d64c02-e070-43b8-9c96-3f7b112c5f7cSPL set ID ab959a35-d0ba-4f18-8f2e-6619d88b16e3RxCUI 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
N461269027160followed by a unit qualifier and the quantityPackage 61269-0271-60. 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.
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 200 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-272 |
| Seroquel XRquetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-270 |
| Seroquel XRquetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-273 |
| Seroquel XRquetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-0281 |
| Seroquel XRquetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | H2-Pharma, LLC | 61269-274 |
| Seroquel XRquetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-0282 |
| 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 |