Quetiapine Fumarate
- Product NDC
- 82804-094
- 11-digit product format
- 828040094
- Labeler code
- 82804
- Product ID
- 82804-094_392dd5cf-4777-4985-b62b-7370134dee26
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 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 |
|---|
| 82804-094-30 | 82804009430 | 30 TABLET in 1 BOTTLE (82804-094-30) | 30 tablet | 2024-04-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate | Proficient Rx LP | 2024-04-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |