Quetiapine Fumarate
- Product NDC
- 68788-8530
- 11-digit product format
- 687888530
- Labeler code
- 68788
- Product ID
- 68788-8530_76df809c-e4b7-4bc7-85c4-482212f459b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA091388
- Marketing category
- ANDA
- Marketing start
- 2023-10-06
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 300 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8530-3 | 68788853003 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8530-3) | 2023-10-06 | No | No | Historical |
| 68788-8530-6 | 68788853006 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8530-6) | 2023-10-06 | No | No | Historical |
| 68788-8530-9 | 68788853009 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8530-9) | 2023-10-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate | Preferred Pharmaceuticals Inc. | 2025-01-16 | HUMAN PRESCRIPTION DRUG LABEL | 2 |