Prescription drug · ANDA
Quetiapine NDC 71335-2641
Quetiapine fumarate 400 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2641-1 | 7133526410171335264101 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2641-1)Marketed from Jun 2, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215478
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-2641_a6ac6b04-2df1-4c0b-9e26-1db660b84d15SPL ID a6ac6b04-2df1-4c0b-9e26-1db660b84d15SPL set ID a373a57d-1dee-4bd1-b71b-494e1662f558RxCUI 721796UNII 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
N471335264101followed by a unit qualifier and the quantityPackage 71335-2641-01. 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.
About NDC 71335-2641
- What is NDC 71335-2641?
- 71335-2641 is the product NDC for Quetiapine, Quetiapine fumarate 400 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quetiapine.
- What is the active ingredient?
- Quetiapine fumarate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quetiapine?
- 86 other product NDCs are listed under this name. See all Quetiapine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Quetiapine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4700 | 70518-4700-00 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4699 | 70518-4699-00 |
| Quetiapine | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0487 | 67046-0487-03 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1623 | 67046-1623-03 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4451 | 70518-4451-00 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4437 | 70518-4437-00 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4430 | 70518-4430-0070518-4430-01 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-598 | 68001-0598-06 |
| Quetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-599 | 68001-0599-06 |
| Quetiapine | Quetiapine fumarate 200 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-600 | 68001-0600-06 |
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 200 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1623 |
| 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 200 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-310 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-308 |
| Quetiapine | Quetiapine fumarate 150 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-309 |
| Quetiapine | Quetiapine fumarate 300 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-311 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-312 |
| Quetiapine | Quetiapine fumarate 50 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-598 |
| 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 300 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-601 |
| Quetiapine | Quetiapine fumarate 400 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-602 |