Prescription drug · ANDA
Quetiapine NDC 68180-616
Quetiapine fumarate 400 mg/1 · Tablet, Film coated, Extended release · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-616-07 | 68180061607 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-616-07)Marketed from Aug 22, 2017 |
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 — 400 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204203
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-616_486bd7e7-86bb-44cb-98fc-33584ddcfe98SPL ID 486bd7e7-86bb-44cb-98fc-33584ddcfe98SPL set ID 7803a290-91c0-4e7f-90b5-d2ff33a46ceeRxCUI 721791, 721794, 721796, 853201, 895670UNII 2S3PL1B6UJUPC 0368180614074, 0368180613077
- 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
N468180061607followed by a unit qualifier and the quantityPackage 68180-0616-07. 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 extended-release tablet 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 tablet USP is indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablet USP 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 to 17 years…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204203
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 200 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-614 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-612 |
| Quetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-613 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-615 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6801 |
| Quetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6802 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6803 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6804 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6805 |