Quetiapine Fumarate
- Product NDC
- 71335-2679
- 11-digit product format
- 713352679
- Labeler code
- 71335
- Product ID
- 71335-2679_ef85575d-f996-4d92-a41b-7e144f1e10e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091388
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 25 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 |
|---|
| 71335-2679-1 | 71335267901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2679-1) | 2025-09-11 | No | No | Historical |
| 71335-2679-2 | 71335267902 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2679-2) | 2025-09-11 | No | No | Historical |
| 71335-2679-3 | 71335267903 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2679-3) | 2025-09-11 | No | No | Historical |
| 71335-2679-4 | 71335267904 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2679-4) | 2025-09-11 | No | No | Historical |
| 71335-2679-5 | 71335267905 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2679-5) | 2025-09-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Quetiapine Fumarate | Bryant Ranch Prepack | 2025-09-11 | HUMAN PRESCRIPTION DRUG LABEL | 1 |