Quetiapine fumarate
- Product NDC
- 68788-8746
- 11-digit product format
- 687888746
- Labeler code
- 68788
- Product ID
- 68788-8746_dda57be5-e0f1-49d5-beca-c7e1b5618192
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA201109
- Marketing category
- ANDA
- Marketing start
- 2024-09-26
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2S3PL1B6UJ | QUETIAPINE FUMARATE | 111974-72-2 | QUETIAPINE FUMARATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8746-1 | 68788874601 | 100 TABLET in 1 BOTTLE (68788-8746-1) | 100 tablet | 2024-09-26 | No | No | Historical |
| 68788-8746-3 | 68788874603 | 30 TABLET in 1 BOTTLE (68788-8746-3) | 30 tablet | 2024-09-26 | No | No | Historical |
| 68788-8746-6 | 68788874606 | 60 TABLET in 1 BOTTLE (68788-8746-6) | 60 tablet | 2024-09-26 | No | No | Historical |
| 68788-8746-8 | 68788874608 | 120 TABLET in 1 BOTTLE (68788-8746-8) | 120 tablet | 2024-09-26 | No | No | Historical |
| 68788-8746-9 | 68788874609 | 90 TABLET in 1 BOTTLE (68788-8746-9) | 90 tablet | 2024-09-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine fumarate | Preferred Pharmaceuticals Inc. | 2025-09-17 | HUMAN PRESCRIPTION DRUG LABEL | 2 |