Prescription drug · ANDA
Quetiapine Fumarate NDC 67046-1588
Quetiapine fumarate 50 mg/1 · Tablet, Film coated · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1588-3 | 67046158803 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1588-3)Marketed from Sep 16, 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 Fumarate
- Generic name (nonproprietary)
- quetiapine fumarate
- Active ingredients
- Quetiapine fumarate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091388
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-1588_3eed125b-9762-9c01-e063-6394a90a4ec2SPL ID 3eed125b-9762-9c01-e063-6394a90a4ec2SPL set ID 3eed13b8-7464-3720-e063-6294a90a1245RxCUI 616487UNII 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
N467046158803followed by a unit qualifier and the quantityPackage 67046-1588-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 091388
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 | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3609 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-1669 |
| Quetiapine Fumarate | Quetiapine fumarate 300 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8530 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2679 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-465 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2691 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8859 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-477 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6337 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2333 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3933 |
| Quetiapine Fumarate | Quetiapine fumarate 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9627 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9623 |
| Quetiapine Fumarate | Quetiapine fumarate 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-489 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3429 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-020 |
| Quetiapine Fumarate | Quetiapine fumarate 200 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-493 |
| Quetiapine Fumarate | Quetiapine fumarate 50 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-490 |
| Quetiapine Fumarate | Quetiapine fumarate 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-491 |
| Quetiapine Fumarate | Quetiapine fumarate 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-492 |
Showing 20 of 37.