Prescription drug · NDA
Seroquel (Quetiapine) NDC 0310-0271
Quetiapine fumarate 100 mg/1 · Tablet, Film coated · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-0271-10 | 0031002711000310027110 | 100 TABLET, FILM COATED in 1 BOTTLE (0310-0271-10)Marketed from Oct 1, 1997 |
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
- Generic name (nonproprietary)
- quetiapine
- Active ingredients
- Quetiapine fumarate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020639
- Marketing start
- Marketing end
- Identifiers
- Product ID 0310-0271_aef69992-4a20-4d55-b85c-7c0799619ce6SPL ID aef69992-4a20-4d55-b85c-7c0799619ce6SPL set ID 0584dda8-bc3c-48fe-1a90-79608f78e8a0RxCUI 153638, 153639, 153640, 284509, 312743, 312744, 312745, 317174, 616483, 616485, 616487, 616489UNII 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
N400310027110followed by a unit qualifier and the quantityPackage 00310-0271-10. 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 is an atypical antipsychotic indicated for the treatment of: • Schizophrenia ( 1.1 ) • Bipolar I disorder manic episodes (1.2) • Bipolar disorder, depressive episodes (1.2) 1.1 Schizophrenia SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). The effectiveness of SEROQUEL for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder SEROQUEL is indicated for the acute treatment of manic episodes associated with bipolar I disorder, bo…
Excerpt only. Read the full label for complete information.
About NDC 0310-0271
- What is NDC 0310-0271?
- 0310-0271 is the product NDC for Seroquel (quetiapine), Quetiapine fumarate 100 mg/1 tablet, film coated, 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 (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?
- 11 other product NDCs are listed under this name. See all Seroquel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Seroquel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Seroquelquetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0278 | 00310-0278-10 |
| Seroquelquetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0279 | 00310-0279-10 |
| Seroquelquetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-251 | 61269-0251-10 |
| Seroquelquetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-255 | 61269-0255-10 |
| Seroquelquetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0274 | 00310-0274-60 |
| Seroquelquetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-254 | 61269-0254-60 |
| Seroquelquetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0272 | 00310-0272-10 |
| Seroquelquetiapine | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0275 | 00310-0275-10 |
| Seroquelquetiapine | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-250 | 61269-0250-10 |
| Seroquelquetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-252 | 61269-0252-10 |
Other NDCs under NDA 020639
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 |
|---|---|---|---|---|
| Seroquelquetiapine | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-250 |
| Seroquelquetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-253 |
| Seroquelquetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-251 |
| Seroquelquetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-252 |
| Seroquelquetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-254 |
| Seroquelquetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | H2-Pharma, LLC | 61269-255 |
| Seroquelquetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0272 |
| Seroquelquetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0274 |
| Seroquelquetiapine | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0275 |
| Seroquelquetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | AstraZeneca Pharmaceuticals LP | 0310-0278 |