Quetiapine Fumarate
- Product NDC
- 80425-0186
- 11-digit product format
- 804250186
- Labeler code
- 80425
- Product ID
- 80425-0186_2a99a7f4-89eb-19db-e063-6294a90a90da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 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 |
|---|
| 80425-0186-3 | 80425018603 | 90 TABLET in 1 BOTTLE (80425-0186-3) | 90 tablet | 2013-03-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 4 |