Prescription drug · ANDA
Quetiapine Fumarate NDC 16729-096
Quetiapine fumarate 300 mg/1 · Tablet, Extended release · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-096-12 | 16729009612 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-096-12)Marketed from Jan 1, 2019 |
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 Fumarate
- Generic name (nonproprietary)
- quetiapine fumarate
- Active ingredients
- Quetiapine fumarate — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Accord Healthcare Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090681
- Marketing start
- Listing expires
- Identifiers
- Product ID 16729-096_4390e24f-daa6-84a2-e063-6294a90a48abSPL ID 4390e24f-daa6-84a2-e063-6294a90a48abSPL set ID 3ffe0294-3959-2755-e054-00144ff8d46cRxCUI 721791, 721794, 721796, 895670UNII 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
N416729009612followed by a unit qualifier and the quantityPackage 16729-0096-12. 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 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 to 17 years) treated wi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090681
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 Fumarate ER | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-481 |
| Quetiapine Fumarate ER | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-482 |
| Quetiapine Fumarate ER | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-483 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Accord Healthcare Inc. | 16729-097 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Accord Healthcare Inc. | 16729-095 |
| Quetiapine Fumarate | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | Accord Healthcare Inc. | 16729-109 |