Prescription drug · ANDA
Quetiapine NDC 68001-598
Quetiapine fumarate 50 mg/1 · Tablet, Extended release · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-598-06 | 68001059806 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-598-06)Marketed from Nov 28, 2023 |
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)
- Quetiapine
- Generic name (nonproprietary)
- quetiapine
- Active ingredients
- Quetiapine fumarate — 50 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215478
- Marketing start
- Listing expires
- Identifiers
- Product ID 68001-598_487e93eb-c251-17da-e063-6294a90a6517SPL ID 487e93eb-c251-17da-e063-6294a90a6517SPL set ID 186c5cde-5066-4436-99ef-28049c12826bRxCUI 721791, 721794, 721796, 853201, 895670UNII 2S3PL1B6UJUPC 0368001602068, 0368001599061, 0368001600064, 0368001601061, 0368001598064
- 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
N468001059806followed by a unit qualifier and the quantityPackage 68001-0598-06. 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)
Quetiapine 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 Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets 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 quetiapine table…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215478
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 |
|---|---|---|---|---|
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4430 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4437 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2641 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-601 |
| Quetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-599 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-600 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-602 |
| Quetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-309 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-308 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-312 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-310 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-311 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1623 |