Quetiapine Fumarate
- Product NDC
- 82804-020
- 11-digit product format
- 828040020
- Labeler code
- 82804
- Product ID
- 82804-020_2b387188-c2c1-4865-984c-341a358d1c6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA091388
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-020-30 | 82804002030 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-020-30) | 2023-10-11 | No | No | Historical |
| 82804-020-60 | 82804002060 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-020-60) | 2023-10-11 | No | No | Historical |
| 82804-020-90 | 82804002090 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-020-90) | 2023-10-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate | Proficient Rx LP | 2023-10-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |